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U.S. Department of Health and Human Services

Class 2 Device Recall Paradym Defibrillators

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  Class 2 Device Recall Paradym Defibrillators see related information
Date Initiated by Firm June 07, 2010
Date Posted September 27, 2010
Recall Status1 Terminated 3 on March 29, 2012
Recall Number Z-2579-2010
Recall Event ID 56199
PMA Number P060027 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - Product Code NIK
Product Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770.
Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy
Code Information 001YH026 811YH056 824YH071 825YH049 825YH089 828YH052 835YH018 836YH016 836YH057 837YH041 851YH00B 903YH050 903YH05F 904YH018 904YH01B 904YH038 907YH017 907YI037 907YI041 909YI036 912YH049 912YH057 912YI009 912YI00A 912YI011 912YI025 912YI026 912YI028 912YI02B 912YI031 912YI048 914YI005 915YH012 915YH014 915YH041 916YH020 916YH028 916YH032 917YH002 917YH003 917YH024 917YH03F 918YH045 918YI029 918YI0A2 919YH02F 919YH03D 919YH044 919YH064 920YI085 920YI089 920YI092 922YH01C 923YH012 923YH023 923YH048 924YH01E 924YH02D 924YH046 925YH015 925YH032 926YH00D 926YH020 926YH037 926YH042 926YH05F 926YI012 926YI032 927YH01A 927YH030 928YH004 928YH01A 928YH033 928YH035 928YI024 928YI02C 928YI045 928YI070 929YH00B 929YH00D 929YH012 929YH019 929YH01C 929YH022 929YH023 929YH033 929YH055 929YI014 929YI030 931YH004 931YH018 931YH035 931YH037 931YH044 931YH04C 931YH052 931YH053 931YH057 931YH059 931YH05E 931YH061 931YH062 931YH063 931YH065 931YH068 931YH069 931YH06B 931YH06C 931YH070 931YH071 931YH072 931YH074 931YH075 931YH07A 931YH081 931YH084 931YI038 931YI066 932YH00B 932YH02E 932YH032 932YH039 932YH03B 932YH04D 932YH052 932YH065 932YH06B 932YH073 932YH0A3 932YH0AD 932YH0B4 932YH0BE 932YI011 932YI08C 933YH007 933YH009 933YH01F 933YH030 933YH060 933YH09D 933YH100 933YH103 933YH105 933YH111 934YH01A 934YH02A 934YH044 934YH04A 935YH005 935YH006 935YH007 935YH015 935YH01D 935YH045 935YH048 935YH058 936YH014 936YH01B 936YH01C 936YH01E 936YH021 936YH023 936YH03A 936YH041 936YH047 936YH062 936YH064 936YH06D 936YH06F 936YH071 936YH078 936YH082 936YH083 937YH01D 937YH022 937YH025 937YH02B 938YH005 938YH01A 938YH01D 938YH03F 939YH00A 939YH02D 940YH005 940YH041 940YH042 940YH057 940YH05A 940YH061 941YH043 942YH02C 943YH01E 943YH025 944YH032 945YH004 945YH00C 945YH01A 945YH053 947YH003 947YH017 947YH01B 947YH01E 947YH027 947YH036 947YH053 947YH057 947YH062 948YH031 948YH037 948YH03B 949YH064 949YH07F 949YH081 949YH084 949YH092 
Recalling Firm/
Manufacturer		 ela Medical Llc
2905 Northwest Blvd Ste 40
Plymouth MN 55441-2673
Manufacturer Reason
for Recall		 The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and to deliver further therapy. The software anomaly could only occurs under a specific sequence of events.
FDA Determined
Cause 2		 Software design
Action Sorin Group issued a "Medical Device Correction" letter dated June 7, 2010 to consignees. The letter described the product, the problem, and actions to be taken by customers. A Sorin Group representative will contact customers to update the software. Prior to receiving the software update, customers should program the exercise AV delay to 40 ms, which will trigger a reset in the event of an anomaly. This will restore normal operation after shock delivery. If the anolmaly occurs on an implanted unit, a RV coil or SVC coil continuity test should be started, which will ensure that the device recovers proper operation. Corin Group can be contacted at 1-615-788-1807.
Quantity in Commerce 215
Distribution Nationwide Distribution in the states of AZ, CA, FL, IA, LA, MA, MS,MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, and VA.
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.
PMA Database PMAs with Product Code = NIK and Original Applicant = MicroPort CRM USA Inc.
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