Boston Scientific Corporation: Medical Device Recall in 2016 - (Recall #: Z-0620-2016)

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, MRI PROPONENT" SR , REF L210 Pacemaker. 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-0620-2016

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: 5

Code Information:

Serial numbers 702961, 702963, 705644, 705666, and 705947.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated