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U.S. Department of Health and Human Services

Class 2 Device Recall Emerge OverTheWire and Emerge Monorail PTCA Dilatation Catheters

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  Class 2 Device Recall Emerge OverTheWire and Emerge Monorail PTCA Dilatation Catheters see related information
Date Initiated by Firm October 24, 2019
Create Date November 26, 2019
Recall Status1 Terminated 3 on March 20, 2023
Recall Number Z-0577-2020
Recall Event ID 84152
510(K)Number K113220  K121196  K130391  K163174  
Product Classification Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
Product Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm;
2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM;
3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm;
4. REF/Catalog No. H7493918912250, EMERGE MR US 2.50MM X 12MM;
5. REF/Catalog No. H7493919312250, EMERGE MR, OUS 2.50mm X 12mm;
6. REF/Catalog No. H7493918912300, EMERGE MR US 3.00MM X 12MM;
7. REF/Catalog No. H7493919312300, EMERGE MR, OUS 3.00mm X 12mm;
8. REF/Catalog No. H7493918915150, EMERGE MR US 1.50MM X 15MM;
9. REF/Catalog No. H7493919315150, EMERGE MR, OUS 1.50mm X 15mm;
10. REF/Catalog No. H7493918915200, EMERGE MR US 2.00MM X 15MM,
11. REF/Catalog No. H7493919315200, EMERGE MR, OUS 2.00mm X 15mm;
12. REF/Catalog No. H7493919315250, EMERGE MR, OUS 2.50mm X 15mm;
13. REF/Catalog No. H7493918915300, EMERGE MR US 3.00MM X 15MM;
14. REF/Catalog No. H7493919315300, EMERGE MR, OUS 3.00mm X 15mm;
15. REF/Catalog No. H7493918915350, EMERGE MR US 3.50MM X 15MM;
16. REF/Catalog No. H7493919315350, EMERGE MR, OUS 3.50mm X 15mm;
17. REF/Catalog No. H7493919320200, EMERGE MR, OUS 2.00mm X 20mm;
18. REF/Catalog No. H7493919320250, EMERGE MR, OUS 2.50mm X 20mm;
19. REF/Catalog No. H7493919320300, EMERGE MR, OUS 3.00mm X 20mm;
20. REF/Catalog No. H7493919415120, EMERGE PUSH MR, OUS 1.20mm X 15mm.
Code Information Lot / GTIN Number / Use By: 1. 24112923 / 8714729799788 / 2022-03-12 2. Lot: 21362152 / 8714729806080 / 2020-07-06, 3. Lots: 21311605 / 8714729799894 / 2020-06-23, 23960557 / 8714729799894 / 2022-02-11, 23975925 / 8714729799894 / 2022-02-13, 24112926 / 8714729799894 / 2022-03-12.  4. Lots: 20524227 / 8714729806103 / 2019-12-31, 22402212 / 8714729806103 / 2021-03-15, 22909685 / 8714729806103 / 2020-12-06.  5. Lots: 23881230 / 8714729799917 / 2022-01-25, 23881291 / 8714729799917 / 2022-01-25, 24088571 / 8714729799917 / 2022-03-07, 24143068 / 8714729799917 / 2022-03-18.  6. Lots: 22374160 / 8714729806127 / 2021-03-09, 22532219 / 8714729806127 / 2021-04-16, 22760617 / 8714729806127 / 2021-02-05, 23021557 / 8714729806127 / 2021-01-11, 23181062 / 8714729806127 / 2021-09-10, 23578933 / 8714729806127 / 2021-04-16.  7. Lot: 22799195 / 8714729799931 / 2021-06-12.  8. Lots: 20361236 / 8714729806189 / 2019-10-31, 22619082 / 8714729806189 / 2021-05-03.  9. Lot: 24088574 / 8714729799993 / 2022-03-07.  10. Lots: 20985435 / 8714729806196 / 2020-04-04, 22416559 / 8714729806196 / 2021-03-19.  11. Lots: 21308852 / 8714729800002 / 2020-06-23, 21309387 / 8714729800002 / 2020-06-23, 21363021 / 8714729800002 / 2020-07-06, 23989173 / 8714729800002 / 2022-02-15.  12. Lots: 20909603 / 8714729800026 / 2020-03-15, 22734757 / 8714729800026 / 2021-05-29, 23047327 / 8714729800026 / 2021-08-03, 23946181 / 8714729800026 / 222-02-07, 24151134 / 8714729800026 / 2022-03-19.  13. Lot: 23924000 / 8714729806233 / 2022-02-04.  14. Lots: 23272475 /8714729800040 / 2021-09-27 , 23541254 / 8714729800040 / 2021-11-20.  15. Lot: 23901505 / 8714729806257 / 2022-01-30.  16. Lot: 24133473 / 8714729800064 / 2022-03-15.  17. Lots: 23272477 / 8714729800118 / 2021-09-21, 23324727 / 8714729800118 / 2021-10-08.  18. Lots: 20452512 / 8714729800132 / 2019-11-30, 20669615 / 8714729800132 / 2020-01-15, 23408005 / 8714729800132 / 2021-10-24.  19. Lots: 21500615 / 8714729800156 / 2020-08-08, 23518523 / 8714729800156 / 2021-11-15.  20. Lot: 23364688 / 8714729799702 / 2021-10-16.  
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		 Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
FDA Determined
Cause 2		 Process control
Action The firm, Boston Scientific, sent an "Urgent Medical Device Removal" letter dated 10/28/2019 overnight mail delivery to its customers. The letter stated the issue, identified affected product and stated that product should not be used. The customers were instructed, if any product is identified to segregate immediately and return to Boston Scientific. The customers were also instructed to Immediately complete the RECALL REMOVAL REPLY VERIFICATION TRACKING FORM and Scan/e-mail to: BSCFieldActionCenter@bsci.com OR Fax to #: 1-866-213-1806. This form must be completed and returned in all cases even if you do not have any affected product. If you are a distributor, please note that the removal notification should be forwarded to your customers. If you have any questions, contact Boston Scientific Quality Systems at 763-494-1133 or email: BSCFieldActionCenter@bsci.com.
Quantity in Commerce 14,145 devices total
Distribution Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LOX and Original Applicant = BOSTON SCIENTIFIC CORP.
510(K)s with Product Code = LOX and Original Applicant = Boston Scientific Corporation
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