FDA Device recall Z-0621-2016
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211 by Boston Scientific, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0621-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-10 |
| Published | 2016-01-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
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.
Identifiers
| code_info | Serial numbers 209409, 209518, and 209609. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0621-2016%22
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