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Class 2 Device Recall Vagus Nerve Stimulation Therapy System |
 |
| Date Initiated by Firm |
November 16, 2018 |
| Create Date |
December 10, 2019 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0663-2020 |
| Recall Event ID |
84170 |
| PMA Number |
P970003 |
| Product Classification |
Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
|
| Product |
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly |
| Code Information |
Serial Number / UDI# GWQ57F2 01054250257504811118060521GWQ57F29910-0011-0500 72S77F2 0105425025750481111806052172S77F29910-0011-0500 1ZFTKJ2 010542502575048111180604211ZFTKJ29910-0011-0500 BRQ57F2 01054250257504811118053121BRQ57F29910-0011-0500 9CP57F2 010542502575048111180529219CP57F29910-0011-0500 HCR77F2 01054250257504811118050421HCR77F29910-0011-0500 H5P57F2 01054250257504811118050321H5P57F29910-0011-0500 19S77F2 0105425025750481111804172119S77F29910-0011-0500 3YFTKJ2 010542502575048111180405213YFTKJ29910-0011-0500 68Q57F2 0105425025750481111803302168Q57F29910-0011-0500 H4S77F2 01054250257504811118031521H4S77F29910-0011-0500 C7KRPJ2 01054250257504811118031521C7KRPJ29910-0011-0500 8WQ77F2 010542502575048111180315218WQ77F29910-0011-0500 1VQ77F2 010542502575048111180315211VQ77F29910-0011-0500 1LJRPJ2 010542502575048111180315211LJRPJ29910-0011-0500 JFJRPJ2 01054250257504811118031421JFJRPJ29910-0011-0500 HVP57F2 01054250257504811118031421HVP57F29910-0011-0500 CBJRPJ2 01054250257504811118031421CBJRPJ29910-0011-0500 9HJRPJ2 010542502575048111180314219HJRPJ29910-0011-0500 1LQ57F2 010542502575048111180313211LQ57F29910-0011-0500 B6S77F2 01054250257504811118030921B6S77F29910-0011-0500 5NT77F2 010542502575048111180309215NT77F29910-0011-0500 75P57F2 0105425025750481111803052175P57F29910-0011-0500 32S77F2 0105425025750481111803052132S77F29910-0011-0500 6P7G1F2 010542502575048111180302216P7G1F29910-0011-0500 1J0C7F2 010542502575048111180228211J0C7F29910-0011-0500 J4R57F2 01054250257504811118022721J4R57F29910-0011-0500 61R77F2 0105425025750481111802272161R77F29910-0011-0500 1C0C7F2 010542502575048111180227211C0C7F29910-0011-0500 1LYB7F2 010542502575048111180226211LYB7F29910-0011-0500 DPS77F2 01054250257504811118021521dps77f29910-0011-0500 9LQ57F2 010542502575048111180215219lq57f29910-0011-0500 HDR77F2 01054250257504811118021421HDR77F29910-0011-0500 B5S77F2 01054250257504811118021421B5S77F29910-0011-0500 HCJRPJ2 01054250257504811118020721HCJRPJ29910-0011-0500 CCT77F2 01054250257504811118020721CCT77F29910-0011-0500 6BR77F2 010542502575048111180207216BR77F29910-0011-0500 4GR77F2 010542502575048111180207214GR77F29910-0011-0500 HDQ57F2 01054250257504811118020621HDQ57F29910-0011-0500 HBKRPJ2 01054250257504811118020621HBKRPJ29910-0011-0500 D9T77F2 01054250257504811118020621D9T77F29910-0011-0500 56JRPJ2 0105425025750481111802062156JRPJ29910-0011-0500 4CR77F2 010542502575048111180206214CR77F29910-0011-0500 2FT77F2 010542502575048111180206212FT77F29910-0011-0500 HWJRPJ2 01054250257504811118020521HWJRPJ29910-0011-0500 9LJRPJ2 010542502575048111180205219LJRPJ29910-0011-0500 F9T0QJ2 01054250257504811118020221F9T0QJ29910-0011-0500 BSZ1QJ2 01054250257504811118020221BSZ1QJ29910-0011-0500 JCJRPJ2 01054250257504811118020121JCJRPJ29910-0011-0500 BXJRPJ2 01054250257504811118020121BXJRPJ29910-0011-0500 B2Q57F2 01054250257504811118020121B2Q57F29910-0011-0500 9BKRPJ2 010542502575048111180201219BKRPJ29910-0011-0500 7GT77F2 010542502575048111180201217GT77F29910-0011-0500 8JJRPJ2 010542502575048111180131218JJRPJ29910-0011-0500 3QJRPJ2 010542502575048111180131213QJRPJ29910-0011-0500 FNT7QJ2 01054250257504811118011821FNT7QJ29910-0011-0500 CNT7QJ2 01054250257504811118011821CNT7QJ29910-0011-0500 77KRPJ2 0105425025750481111801182177KRPJ29910-0011-0500 1VZ1QJ2 010542502575048111180118211VZ1QJ29910-0011-0500 1QJRPJ2 010542502575048111180118211QJRPJ29910-0011-0500 19T0QJ2 0105425025750481111801182119T0QJ29910-0011-0500 5CD820D5WV 010542502575042911180920215CD820D5WV9910-0011-8701 5CD8212Q6W 010542502575042911180919215CD8212Q6W9910-0011-8701 5CD8212Q6M 010542502575042911180919215CD8212Q6M9910-0011-8701 5CD8212Q57 010542502575042911180919215CD8212Q579910-0011-8701 5CD8212Q55 010542502575042911180919215CD8212Q559910-0011-8701 5CD8212Q51 010542502575042911180919215CD8212Q519910-0011-8701 5CD8212Q44 010542502575042911180919215CD8212Q449910-0011-8701 5CD8212Q1R 010542502575042911180919215CD8212Q1R9910-0011-8701 5CD820D60D 010542502575042911180919215CD820D60D9910-0011-8701 5CD820D5Z6 010542502575042911180919215CD820D5Z69910-0011-8701 5CD820D5WK 010542502575042911180919215CD820D5WK9910-0011-8701 5CD820D5VG 010542502575042911180919215CD820D5VG9910-0011-8701 5CD820D5TP 010542502575042911180919215CD820D5TP9910-0011-8701 5CD820D5TB 010542502575042911180919215CD820D5TB9910-0011-8701 5CD820D5T7 010542502575042911180919215CD820D5T79910-0011-8701 5CD820D5SN 010542502575042911180919215CD820D5SN9910-0011-8701 5CD820D5RT 010542502575042911180919215CD820D5RT9910-0011-8701 5CD820D5R6 010542502575042911180919215CD820D5R69910-0011-8701 5CD8212Q9X 010542502575042911180918215CD8212Q9X9910-0011-8701 5CD8212Q9W 010542502575042911180918215CD8212Q9W9910-0011-8701 5CD8212Q94 010542502575042911180918215CD8212Q949910-0011-8701 5CD8212Q8R 010542502575042911180918215CD8212Q8R9910-0011-8701 5CD8212Q60 010542502575042911180918215CD8212Q609910-0011-8701 5CD8212Q3Y 010542502575042911180918215CD8212Q3Y9910-0011-8701 5CD8212Q3F 010542502575042911180918215CD8212Q3F9910-0011-8701 5CD8212Q33 010542502575042911180918215CD8212Q339910-0011-8701 5CD8212Q2Y 010542502575042911180918215CD8212Q2Y9910-0011-8701 5CD8212Q12 010542502575042911180918215CD8212Q129910-0011-8701 5CD8212PYM 010542502575042911180918215CD8212PYM9910-0011-8701 5CD820D60G 010542502575042911180918215CD820D60G9910-0011-8701 5CD820D5Z2 010542502575042911180918215CD820D5Z29910-0011-8701 5CD820D5YR 010542502575042911180918215CD820D5YR9910-0011-8701 5CD820D5YP 010542502575042911180918215CD820D5YP9910-0011-8701 5CD8212QCW 010542502575042911180914215CD8212QCW9910-0011-8701 5CD8212Q9J 010542502575042911180914215CD8212Q9J9910-0011-8701 5CD8212Q8C 010542502575042911180914215CD8212Q8C9910-0011-8701 5CD8212Q89 010542502575042911180914215CD8212Q899910-0011-8701 5CD8212Q82 010542502575042911180914215CD8212Q829910-0011-8701 5CD8212Q4M 010542502575042911180914215CD8212Q4M9910-0011-8701 5CD8212Q3H 010542502575042911180914215CD8212Q3H9910-0011-8701 5CD8212Q02 010542502575042911180914215CD8212Q029910-0011-8701 5CD820D62P 010542502575042911180914215CD820D62P9910-0011-8701 5CD820D616 010542502575042911180914215CD820D6169910-0011-8701 5CD820D615 010542502575042911180914215CD820D6159910-0011-8701 5CD820D613 010542502575042911180914215CD820D6139910-0011-8701 5CD820D60Z 010542502575042911180914215CD820D60Z9910-0011-8701 5CD820D60Q 010542502575042911180914215CD820D60Q9910-0011-8701 5CD820D60L 010542502575042911180914215CD820D60L9910-0011-8701 5CD820D60J 010542502575042911180914215CD820D60J9910-0011-8701 5CD820D60H 010542502575042911180914215CD820D60H9910-0011-8701 5CD820D605 010542502575042911180914215CD820D6059910-0011-8701 5CD820D602 010542502575042911180914215CD820D6029910-0011-8701 5CD820D5YT 010542502575042911180914215CD820D5YT9910-0011-8701 5CD820D5YN 010542502575042911180914215CD820D5YN9910-0011-8701 5CD820D5YF 010542502575042911180914215CD820D5YF9910-0011-8701 5CD8212QBN 010542502575042911180912215CD8212QBN9910-0011-8701 5CD8212QBG 010542502575042911180912215CD8212QBG9910-0011-8701 5CD8212Q5X 010542502575042911180912215CD8212Q5X9910-0011-8701 5CD8212Q2G 010542502575042911180912215CD8212Q2G9910-0011-8701 5CD820D645 010542502575042911180912215CD820D6459910-0011-8701 5CD820D628 010542502575042911180912215CD820D6289910-0011-8701 5CD820D61Q 010542502575042911180912215CD820D61Q9910-0011-8701 5CD820D61C 010542502575042911180912215CD820D61C9910-0011-8701 5CD820D61B 010542502575042911180912215CD820D61B9910-0011-8701 5CD820D60W 010542502575042911180912215CD820D60W9910-0011-8701 5CD820D608 010542502575042911180912215CD820D6089910-0011-8701 5CD820D607 010542502575042911180912215CD820D6079910-0011-8701 5CD820D5ZW 010542502575042911180912215CD820D5ZW9910-0011-8701 5CD820D5ZV 010542502575042911180912215CD820D5ZV9910-0011-8701 5CD820D5Z9 010542502575042911180912215CD820D5Z99910-0011-8701 5CD820D5YD 010542502575042911180912215CD820D5YD9910-0011-8701 5CD820D5Y0 010542502575042911180912215CD820D5Y09910-0011-8701 5CD820D5WT 010542502575042911180912215CD820D5WT9910-0011-8701 5CD820D5V3 010542502575042911180912215CD820D5V39910-0011-8701 5CD820D5RS 010542502575042911180912215CD820D5RS9910-0011-8701 5CD820D5LL 010542502575042911180912215CD820D5LL9910-0011-8701 5CD820D5HZ 010542502575042911180912215CD820D5HZ9910-0011-8701 5CD820D5HS 010542502575042911180912215CD820D5HS9910-0011-8701 5CD820D5GL 010542502575042911180912215CD820D5GL9910-0011-8701 5CD820D5BF 010542502575042911180912215CD820D5BF9910-0011-8701 5CD820D5B3 010542502575042911180912215CD820D5B39910-0011-8701 5CD820D598 010542502575042911180912215CD820D5989910-0011-8701 5CD8212QDW 010542502575042911180911215CD8212QDW9910-0011-8701 5CD8212QDM 010542502575042911180911215CD8212QDM9910-0011-8701 5CD8212QDL 010542502575042911180911215CD8212QDL9910-0011-8701 5CD8212QB9 010542502575042911180911215CD8212QB99910-0011-8701 5CD8212Q96 010542502575042911180911215CD8212Q969910-0011-8701 5CD8212Q71 010542502575042911180911215CD8212Q719910-0011-8701 5CD8212Q5D 010542502575042911180911215CD8212Q5D9910-0011-8701 5CD8212Q2X 010542502575042911180911215CD8212Q2X9910-0011-8701 5CD8212Q1M 010542502575042911180911215CD8212Q1M9910-0011-8701 5CD8212Q1K 010542502575042911180911215CD8212Q1K9910-0011-8701 5CD820D62D 010542502575042911180911215CD820D62D9910-0011-8701 5CD820D61S 010542502575042911180911215CD820D61S9910-0011-8701 5CD820D617 010542502575042911180911215CD820D6179910-0011-8701 5CD820D60P 010542502575042911180911215CD820D60P9910-0011-8701 5CD820D5YK 010542502575042911180911215CD820D5YK9910-0011-8701 5CD820D5X2 010542502575042911180911215CD820D5X29910-0011-8701 5CD820D5WS 010542502575042911180911215CD820D5WS9910-0011-8701 5CD820D5TV 010542502575042911180911215CD820D5TV9910-0011-8701 5CD820D5SX 010542502575042911180911215CD820D5SX9910-0011-8701 5CD820D5QW 010542502575042911180911215CD820D5QW9910-0011-8701 5CD820D5G4 010542502575042911180911215CD820D5G49910-0011-8701 5CD820D5FV 010542502575042911180911215CD820D5FV9910-0011-8701 5CD8212QDY 010542502575042911180910215CD8212QDY9910-0011-8701 5CD8212QD8 010542502575042911180910215CD8212QD89910-0011-8701 5CD8212QBD 010542502575042911180910215CD8212QBD9910-0011-8701 5CD8212Q59 010542502575042911180910215CD8212Q599910-0011-8701 5CD8212Q4X 010542502575042911180910215CD8212Q4X9910-0011-8701 5CD8212Q2D 010542502575042911180910215CD8212Q2D9910-0011-8701 5CD8212Q23 010542502575042911180910215CD8212Q239910-0011-8701 5CD8212Q0T 010542502575042911180910215CD8212Q0T9910-0011-8701 5CD8212PYR 010542502575042911180910215CD8212PYR9910-0011-8701 5CD820D5VY 010542502575042911180910215CD820D5VY9910-0011-8701 5CD820D5TF 010542502575042911180910215CD820D5TF9910-0011-8701 5CD820D5T0 010542502575042911180910215CD820D5T09910-0011-8701 5CD820D5SV 010542502575042911180910215CD820D5SV9910-0011-8701 5CD820D5SS 010542502575042911180910215CD820D5SS9910-0011-8701 5CD820D5SC 010542502575042911180910215CD820D5SC9910-0011-8701 5CD820D5S8 010542502575042911180910215CD820D5S89910-0011-8701 5CD820D5S5 010542502575042911180910215CD820D5S59910-0011-8701 5CD820D5RZ 010542502575042911180910215CD820D5RZ9910-0011-8701 5CD820D5RM 010542502575042911180910215CD820D5RM9910-0011-8701 5CD820D5R9 010542502575042911180910215CD820D5R99910-0011-8701 5CD820D5QS 010542502575042911180910215CD820D5QS9910-0011-8701 5CD820D5QB 010542502575042911180910215CD820D5QB9910-0011-8701 5CD820D5N0 010542502575042911180910215CD820D5N09910-0011-8701 5CD820D5LT 010542502575042911180910215CD820D5LT9910-0011-8701 5CD820D5LK 010542502575042911180910215CD820D5LK9910-0011-8701 5CD820D5BT 010542502575042911180910215CD820D5BT9910-0011-8701 5CD8212QF2 010542502575042911180907215CD8212QF29910-0011-8701 5CD8212QDF 010542502575042911180907215CD8212QDF9910-0011-8701 5CD8212QCK 010542502575042911180907215CD8212QCK9910-0011-8701 5CD8212Q78 010542502575042911180907215CD8212Q789910-0011-8701 5CD8212Q4T 010542502575042911180907215CD8212Q4T9910-0011-8701 5CD8212Q3T 010542502575042911180907215CD8212Q3T9910-0011-8701 5CD8212Q3D 010542502575042911180907215CD8212Q3D9910-0011-8701 5CD8212PYK 010542502575042911180907215CD8212PYK9910-0011-8701 5CD820D611 010542502575042911180907215CD820D6119910-0011-8701 5CD820D5W9 010542502575042911180907215CD820D5W99910-0011-8701 5CD820D5S3 010542502575042911180907215CD820D5S39910-0011-8701 5CD820D5S1 010542502575042911180907215CD820D5S19910-0011-8701 5CD820D5Q7 010542502575042911180907215CD820D5Q79910-0011-8701 5CD820D5PG 010542502575042911180907215CD820D5PG9910-0011-8701 5CD820D5MW 010542502575042911180907215CD820D5MW9910-0011-8701 5CD820D5MM 010542502575042911180907215CD820D5MM9910-0011-8701 5CD8212QF6 010542502575042911180821215CD8212QF69910-0011-8701 5CD8212QF4 010542502575042911180821215CD8212QF49910-0011-8701 5CD8212QDZ 010542502575042911180821215CD8212QDZ9910-0011-8701 5CD8212QDV 010542502575042911180821215CD8212QDV9910-0011-8701 5CD8212QDS 010542502575042911180821215CD8212QDS9910-0011-8701 5CD8212QDH 010542502575042911180821215CD8212QDH9910-0011-8701 5CD8212QD9 010542502575042911180821215CD8212QD99910-0011-8701 5CD8212QD7 010542502575042911180821215CD8212QD79910-0011-8701 5CD8212QD6 010542502575042911180821215CD8212QD69910-0011-8701 5CD8212QC4 010542502575042911180821215CD8212QC49910-0011-8701 5CD8212QBW 010542502575042911180821215CD8212QBW9910-0011-8701 5CD8212QBH 010542502575042911180821215CD8212QBH9910-0011-8701 5CD8212Q9M 010542502575042911180821215CD8212Q9M9910-0011-8701 5CD8212Q98 010542502575042911180821215CD8212Q989910-0011-8701 5CD8212Q8X 010542502575042911180821215CD8212Q8X9910-0011-8701 5CD8212Q8T 010542502575042911180821215CD8212Q8T9910-0011-8701 5CD8212Q7R 010542502575042911180821215CD8212Q7R9910-0011-8701 5CD8212Q74 010542502575042911180821215CD8212Q749910-0011-8701 5CD8212Q6T 010542502575042911180821215CD8212Q6T9910-0011-8701 5CD8212Q6S 010542502575042911180821215CD8212Q6S9910-0011-8701 5CD8212Q67 010542502575042911180821215CD8212Q679910-0011-8701 5CD8212Q5Z 010542502575042911180821215CD8212Q5Z9910-0011-8701 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5CD820D5YZ 010542502575042911180815215CD820D5YZ9910-0011-8701 5CD820D5YW 010542502575042911180815215CD820D5YW9910-0011-8701 5CD820B1VN 010542502575042911180815215CD820B1VN9910-0011-8701 5CD820B1VL 010542502575042911180815215CD820B1VL9910-0011-8701 5CD820B1V0 010542502575042911180815215CD820B1V09910-0011-8701 5CD820B1TK 010542502575042911180815215CD820B1TK9910-0011-8701 5CD820B1T9 010542502575042911180815215CD820B1T99910-0011-8701 5CD820B1SV 010542502575042911180815215CD820B1SV9910-0011-8701 5CD820B1S2 010542502575042911180815215CD820B1S29910-0011-8701 5CD820B1QW 010542502575042911180815215CD820B1QW9910-0011-8701 5CD8212QF5 010542502575042911180814215CD8212QF59910-0011-8701 5CD8212QF3 010542502575042911180814215CD8212QF39910-0011-8701 5CD8212QDX 010542502575042911180814215CD8212QDX9910-0011-8701 5CD8212QDT 010542502575042911180814215CD8212QDT9910-0011-8701 5CD8212QDQ 010542502575042911180814215CD8212QDQ9910-0011-8701 5CD8212QDB 010542502575042911180814215CD8212QDB9910-0011-8701 5CD8212QBZ 010542502575042911180814215CD8212QBZ9910-0011-8701 5CD8212Q8N 010542502575042911180814215CD8212Q8N9910-0011-8701 5CD8212Q8L 010542502575042911180814215CD8212Q8L9910-0011-8701 5CD8212Q86 010542502575042911180814215CD8212Q869910-0011-8701 5CD8212Q7Z 010542502575042911180814215CD8212Q7Z9910-0011-8701 5CD8212Q7W 010542502575042911180814215CD8212Q7W9910-0011-8701 5CD8212Q6X 010542502575042911180814215CD8212Q6X9910-0011-8701 5CD8212Q4S 010542502575042911180814215CD8212Q4S9910-0011-8701 5CD8212Q4D 010542502575042911180814215CD8212Q4D9910-0011-8701 5CD8212Q04 010542502575042911180814215CD8212Q049910-0011-8701 5CD8212Q01 010542502575042911180814215CD8212Q019910-0011-8701 5CD8212PYY 010542502575042911180814215CD8212PYY9910-0011-8701 5CD8212PYB 010542502575042911180814215CD8212PYB9910-0011-8701 5CD820D679 010542502575042911180814215CD820D6799910-0011-8701 5CD820D672 010542502575042911180814215CD820D6729910-0011-8701 5CD820D66Q 010542502575042911180814215CD820D66Q9910-0011-8701 5CD820D66K 010542502575042911180814215CD820D66K9910-0011-8701 5CD820D66J 010542502575042911180814215CD820D66J9910-0011-8701 5CD820D656 010542502575042911180814215CD820D6569910-0011-8701 5CD820D64R 010542502575042911180814215CD820D64R9910-0011-8701 5CD820D64Q 010542502575042911180814215CD820D64Q9910-0011-8701 5CD820D64C 010542502575042911180814215CD820D64C9910-0011-8701 5CD820D641 010542502575042911180814215CD820D6419910-0011-8701 5CD820D63T 010542502575042911180814215CD820D63T9910-0011-8701 5CD820D63F 010542502575042911180814215CD820D63F9910-0011-8701 5CD820D62R 010542502575042911180814215CD820D62R9910-0011-8701 5CD820D5ZK 010542502575042911180814215CD820D5ZK9910-0011-8701 5CD820D5Y8 010542502575042911180814215CD820D5Y89910-0011-8701 5CD820D5S6 010542502575042911180814215CD820D5S69910-0011-8701 5CD820D5NS 010542502575042911180814215CD820D5NS9910-0011-8701 5CD820D5L2 010542502575042911180814215CD820D5L29910-0011-8701 5CD820B1Q0 010542502575042911180814215CD820B1Q09910-0011-8701 5CD8212Q3R 010542502575042911180813215CD8212Q3R9910-0011-8701 5CD8212Q3Q 010542502575042911180813215CD8212Q3Q9910-0011-8701 5CD8212Q3P 010542502575042911180813215CD8212Q3P9910-0011-8701 5CD8212Q3N 010542502575042911180813215CD8212Q3N9910-0011-8701 5CD8212Q3M 010542502575042911180813215CD8212Q3M9910-0011-8701 5CD8212Q3K 010542502575042911180813215CD8212Q3K9910-0011-8701 5CD8212Q3G 010542502575042911180813215CD8212Q3G9910-0011-8701 5CD8212Q3C 010542502575042911180813215CD8212Q3C9910-0011-8701 5CD8212Q3B 010542502575042911180813215CD8212Q3B9910-0011-8701 5CD8212Q36 010542502575042911180813215CD8212Q369910-0011-8701 5CD8212Q2W 010542502575042911180813215CD8212Q2W9910-0011-8701 5CD8212Q2V 010542502575042911180813215CD8212Q2V9910-0011-8701 5CD8212Q2T 010542502575042911180813215CD8212Q2T9910-0011-8701 5CD8212Q2S 010542502575042911180813215CD8212Q2S9910-0011-8701 5CD8212Q27 010542502575042911180813215CD8212Q279910-0011-8701 5CD8212Q26 010542502575042911180813215CD8212Q269910-0011-8701 5CD8212Q21 010542502575042911180813215CD8212Q219910-0011-8701 5CD8212Q1Z 010542502575042911180813215CD8212Q1Z9910-0011-8701 5CD8212Q1T 010542502575042911180813215CD8212Q1T9910-0011-8701 5CD8212Q1S 010542502575042911180813215CD8212Q1S9910-0011-8701 5CD8212Q1Q 010542502575042911180813215CD8212Q1Q9910-0011-8701 5CD8212Q1N 010542502575042911180813215CD8212Q1N9910-0011-8701 5CD8212Q1L 010542502575042911180813215CD8212Q1L9910-0011-8701 5CD8212Q1F 010542502575042911180813215CD8212Q1F9910-0011-8701 5CD8212Q18 010542502575042911180813215CD8212Q189910-0011-8701 5CD8212Q15 010542502575042911180813215CD8212Q159910-0011-8701 5CD8212Q0X 010542502575042911180813215CD8212Q0X9910-0011-8701 5CD8212Q0Q 010542502575042911180813215CD8212Q0Q9910-0011-8701 5CD8212Q0N 010542502575042911180813215CD8212Q0N9910-0011-8701 5CD8212Q0G 010542502575042911180813215CD8212Q0G9910-0011-8701 5CD8212Q0F 010542502575042911180813215CD8212Q0F9910-0011-8701 5CD8212Q0D 010542502575042911180813215CD8212Q0D9910-0011-8701 5CD8212Q0B 010542502575042911180813215CD8212Q0B9910-0011-8701 5CD8212Q08 010542502575042911180813215CD8212Q089910-0011-8701 5CD8212PZW 010542502575042911180813215CD8212PZW9910-0011-8701 5CD8212PZV 010542502575042911180813215CD8212PZV9910-0011-8701 5CD8212PZS 010542502575042911180813215CD8212PZS9910-0011-8701 5CD8212PZP 010542502575042911180813215CD8212PZP9910-0011-8701 5CD8212PZD 010542502575042911180813215CD8212PZD9910-0011-8701 5CD8212PZC 010542502575042911180813215CD8212PZC9910-0011-8701 5CD8212PZ4 010542502575042911180813215CD8212PZ49910-0011-8701 5CD8212PZ3 010542502575042911180813215CD8212PZ39910-0011-8701 5CD8212PYP 010542502575042911180813215CD8212PYP9910-0011-8701 5CD820D67L 010542502575042911180813215CD820D67L9910-0011-8701 5CD820D66Y 010542502575042911180813215CD820D66Y9910-0011-8701 5CD820D66T 010542502575042911180813215CD820D66T9910-0011-8701 5CD820D66P 010542502575042911180813215CD820D66P9910-0011-8701 5CD820D662 010542502575042911180813215CD820D6629910-0011-8701 5CD820D65W 010542502575042911180813215CD820D65W9910-0011-8701 5CD820D65S 010542502575042911180813215CD820D65S9910-0011-8701 5CD820D657 010542502575042911180813215CD820D6579910-0011-8701 5CD820D623 010542502575042911180813215CD820D6239910-0011-8701 5CD820D60K 010542502575042911180813215CD820D60K9910-0011-8701 5CD820D603 010542502575042911180813215CD820D6039910-0011-8701 5CD820D5ZF 010542502575042911180813215CD820D5ZF9910-0011-8701 5CD820D5PC 010542502575042911180813215CD820D5PC9910-0011-8701 5CD820D5NR 010542502575042911180813215CD820D5NR9910-0011-8701 5CD820D5NJ 010542502575042911180813215CD820D5NJ9910-0011-8701 5CD820D5JC 010542502575042911180813215CD820D5JC9910-0011-8701 5CD820D5G3 010542502575042911180813215CD820D5G39910-0011-8701 5CD820B1XX 010542502575042911180813215CD820B1XX9910-0011-8701 5CD820B1VZ 010542502575042911180813215CD820B1VZ9910-0011-8701 5CD820B1VG 010542502575042911180813215CD820B1VG9910-0011-8701 5CD820B1V7 010542502575042911180813215CD820B1V79910-0011-8701 5CD820B1TZ 010542502575042911180813215CD820B1TZ9910-0011-8701 5CD820B1TS 010542502575042911180813215CD820B1TS9910-0011-8701 5CD820B1TN 010542502575042911180813215CD820B1TN9910-0011-8701 5CD820B1TG 010542502575042911180813215CD820B1TG9910-0011-8701 5CD820B1T6 010542502575042911180813215CD820B1T69910-0011-8701 5CD820B1SY 010542502575042911180813215CD820B1SY9910-0011-8701 5CD820B1SK 010542502575042911180813215CD820B1SK9910-0011-8701 5CD820B1S1 010542502575042911180813215CD820B1S19910-0011-8701 5CD820B1RS 010542502575042911180813215CD820B1RS9910-0011-8701 5CD820B1RH 010542502575042911180813215CD820B1RH9910-0011-8701 5CD820B1R9 010542502575042911180813215CD820B1R99910-0011-8701 5CD820B1QV 010542502575042911180813215CD820B1QV9910-0011-8701 5CD820D5XM 010542502575042911180810215CD820D5XM9910-0011-8701 5CD820D5PZ 010542502575042911180810215CD820D5PZ9910-0011-8701 5CD820D5PX 010542502575042911180810215CD820D5PX9910-0011-8701 5CD820D5P8 010542502575042911180810215CD820D5P89910-0011-8701 5CD820D5LN 010542502575042911180810215CD820D5LN9910-0011-8701 5CD820D5LH 010542502575042911180810215CD820D5LH9910-0011-8701 5CD820D5FW 010542502575042911180810215CD820D5FW9910-0011-8701 5CD820D5DD 010542502575042911180810215CD820D5DD9910-0011-8701 5CD820D5D6 010542502575042911180810215CD820D5D69910-0011-8701 5CD820B1XF 010542502575042911180810215CD820B1XF9910-0011-8701 5CD820B1T8 010542502575042911180810215CD820B1T89910-0011-8701 5CD8212Q7F 010542502575042911180809215CD8212Q7F9910-0011-8701 5CD820D65R 010542502575042911180809215CD820D65R9910-0011-8701 5CD820D5Q8 010542502575042911180809215CD820D5Q89910-0011-8701 5CD820D5P6 010542502575042911180809215CD820D5P69910-0011-8701 5CD820D59W 010542502575042911180809215CD820D59W9910-0011-8701 5CD820D60R 010542502575042911180807215CD820D60R9910-0011-8701 5CD820D5DF 010542502575042911180807215CD820D5DF9910-0011-8701 5CD820B1QB 010542502575042911180807215CD820B1QB9910-0011-8701 B5R57F2 01054250257503991117092721B5R57F29910-0011-0500 CPP57F2 01054250257503991117092521CPP57F29910-0011-0500 CKR57F2 01054250257503991117092521CKR57F29910-0011-0500 CHQ57F2 01054250257503991117092521CHQ57F29910-0011-0500 B0R57F2 01054250257503991117092321B0R57F29910-0011-0500 8HR57F2 010542502575039911170923218HR57F2 9910-0011-0500 7MS77F2 010542502575039911170922217MS77F2 9910-0011-0500 CMS77F2 01054250257503991117092121CMS77F2 9910-0011-0500 FDQ57F2 01054250257503991117092021FDQ57F2 9910-0011-0500 F1Q57F2 01054250257503991117092021F1Q57F2 9910-0011-0500 6CQ57F2 010542502575039911170920216CQ57F2 9910-0011-0500 B7Q57F2 01054250257503991117091821B7Q57F2 9910-0011-0500 7XR77F2 010542502575039911 170918217XR77F2 9910-0011-0500 7XP57F2 010542502575039911 170918217XP57F2 9910-0011-0500 |
Recalling Firm/
Manufacturer |
LivaNova USA Inc
100 Cyberonics Blvd
Houston TX 77058-2069
|
| For Additional Information Contact |
Customer Support
866-882-8804
|
Manufacturer Reason
for Recall |
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
|
FDA Determined
Cause 2 |
Software design |
| Action |
On November 16, 2018 LivaNova mailed a "Medical Device Correction" letter via 1st class mail to affected Doctors informing them about the recall. The letter asked doctor's to do the following:
1.When performing System Diagnostics on patients implanted with a Model 102 or 102R generator, do one of the following:
a. Use any of the following Programming System software versions: Model 250 8.1/11.0; Model 3000 version 1.0; or b. If one of the above Programming Systems software versions is not available, complete the following steps to perform System Diagnostics using Model
3000 version 1.5 software:
i. Interrogate the device, noting the devices current settings,
ii. Program normal mode output current to 0mA,
iii. Perform System Diagnostics as usual,
iv. Re-interrogate the device,
v. Program the devices normal mode output current back to the settings noted in step (i) above, and;
vi. Interrogate the device to verify settings are as intended prior to the patient leaving the office visit.
2. Please complete and return the attached Customer Response Form by fax to 281-853-1248 or by e-mail to M3000FieldAction@livanova.com.
3. Please ensure that this notice is communicated to all personnel within your organization who need to be aware of it.
4. For questions regarding the information in this letter, please contact Clinical Technical
Support at (866) 882-8804 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at cservices@livanova.com. |
| Quantity in Commerce |
643 units |
| Distribution |
IL,
AK,
AL,
AR,
AZ,
CA,
CA ,
CO,
CT,
DC,
DE,
FL,
GA,
HI,
IA,
ID,
IL,
IN,
KS,
KY,
LA,
MA,
MD
MI,
MN,
MO,
MS,
MT,
NC,
ND,
NE,
NE,
NJ,
NM,
NV,
NY,
OH,
OK,
OR,
PA,
SC,
SD,
TN,
TX,
UT,
VA,
WA,
WA ,
WI,
WV,
WY, |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| PMA Database |
PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.
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