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Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (s...

FDA Recall #Z-0621-2016 — Class II — December 10, 2015

Recall #Z-0621-2016 Date: December 10, 2015 Classification: Class II Status: Terminated

Product Description

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

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.

Recalling Firm

Boston Scientific Corporation — Saint Paul, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3

Distribution

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

Code Information

Serial numbers 209409, 209518, and 209609.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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