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U.S. Department of Health and Human Services

Class 2 Device Recall PROPONENT DR Pacemakers

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 Class 2 Device Recall PROPONENT DR Pacemakerssee related information
Date Initiated by FirmDecember 10, 2015
Date PostedJanuary 08, 2016
Recall Status1 Terminated 3 on March 08, 2016
Recall NumberZ-0621-2016
Recall Event ID 72855
Product Classification Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
ProductBoston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Code Information Serial numbers 209409, 209518, and 209609. 
FEI Number 2124215
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information ContactBoston Scientific Representative
800-227-3422
Manufacturer Reason
for Recall		The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
FDA Determined
Cause 2		Labeling mix-ups
ActionThe firm, Boston Scientific, sent a "Medical Device Retrieval" letter dated December 2015 to its Consignees on 12/10/2015. The letter described the problem, product involved in the recall and actions to be taken. The consignees were instructed to immediately segregate the product to ensure that it will not be used, obtain an IAN (inventory authorization number) from Boston Scientific's Logistics Department by email at randall.peterfeso@bsci.com; return it back to Boston Scientific-Clonmel Cashel Rd., Clonmel Co Tipperary Ireland. If you have any questions about this retrieval contact your local Boston Scientific representative or a Technical Services representatives at 1-800-CARDIAC (227-3422) tech.services@bsci.com or randall.peterfeso@bsci.com.
Quantity in Commerce3
DistributionInternational Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
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.
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