PROPONENT VDD SL Pacemaker — Class II medical device recall Z-0376-2018
Ongoing recall by Boston Scientific Corporation, reported 2018-01-24, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor sign
| Recall number | Z-0376-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2017-12-07 |
| Classified | 2018-01-15 |
| Reported by FDA | 2018-01-24 |
| Distributed | 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 |
| Model numbers | L209NOT |
Product
PROPONENT VDD SL Pacemaker
Reason for recall
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).
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.