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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific, INGEVITY MRI Leads, Sterile EO, RxOnly.

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 Class 2 Device Recall Boston Scientific, INGEVITY MRI Leads, Sterile EO, RxOnly.see related information
Date Initiated by FirmNovember 30, 2016
Create DateDecember 30, 2016
Recall Status1 Terminated 3 on December 13, 2017
Recall NumberZ-0938-2017
Recall Event ID 75813
PMA NumberP150012 
Product Classification Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
ProductBoston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Code Information Model 7740  S/N 633464, 610662. Model 7741  S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742  S/N 572200, 584869, 631202. Model 7732  S/N 488740. Model 7736  S/N 631322, 632188. 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
651-582-4000
Manufacturer Reason
for Recall		Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.
FDA Determined
Cause 2		Process control
ActionBoston Scientific sent an "Important Medical Device Information" letter dated November 30, 2016. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also described the "Clinical Considerations, Recommendations, Affected Population & Further Information". For questions contact your local Boston Scientific representative or Technical Services. For further questions, please call ( 651) 582-4000.
Quantity in Commerce15 (2 US; 13 OUS)
DistributionWorldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LWP
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