—#142361

Product

Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

FDA product code: LWP — Implantable Pulse Generator, Pacemaker (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Serial numbers 209409, 209518, and 209609.

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

The 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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.

Timeline

Recall initiated: 2015-12-10
Posted by FDA: 2016-01-08
Terminated: 2016-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142361. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.