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Recall Observatory FDA recall evidence

Device product

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

Z-0621-2016

December 10, 2015

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 72855
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0621-2016

Official wording

Reason: 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.

Code information: Serial numbers 209409, 209518, and 209609.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.