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Terminated

Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary

FDA Recall Z-0620-2016 · Posted 2016-01-08

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLWP
Date Initiated2015-12-10
Date Terminated2016-03-08
Product Quantity5

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.

Firm Action

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 [email protected]; 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) [email protected] or [email protected].

Root Cause

Labeling mix-ups

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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