FDA Device recall Z-0620-2016
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker 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-0620-2016 |
| 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, MRI PROPONENT" SR , REF L210 Pacemaker. 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 702961, 702963, 705644, 705666, and 705947. |
|---|
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-0620-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.