Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and

FDA device recall Z-0621-2016 · posted 2016-01-08 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

LWP

Quantity affected

3

Distribution

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

Date initiated

2015-12-10

Date posted

2016-01-08

Date terminated

2016-03-08

Location

Saint Paul, MN