ACCOLADE Pacemaker — Class II medical device recall Z-3257-2018
Terminated recall by Boston Scientific Corporation, reported 2018-10-03, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential fo
| Recall number | Z-3257-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2018-09-10 |
| Classified | 2018-09-27 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2019-11-04 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WI, WV, WY |
| Model numbers | L300, L301, L310, L311, L321, L331 |
Product
ACCOLADE Pacemaker
Reason for recall
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3257-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.