FDA Device recall Z-0375-2018
PROPONENT EL DR Pacemaker
- FDA Device
- Class II
- ongoing
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of PROPONENT EL DR Pacemaker by Boston Scientific, citing boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchroniza….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0375-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-12-07 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
PROPONENT EL DR Pacemaker
Reason
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Identifiers
| code_info | Model L221 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0375-2018%22
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