Boston Scientific Corporation: Medical Device Recall in 2016 - (Recall #: Z-0621-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 10, 2015

Date Posted: January 20, 2016

Recall Number: Z-0621-2016

Event ID: 72855

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.

Status: Terminated

Product Quantity: 3

Code Information:

Serial numbers 209409, 209518, and 209609.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated