Accolade pacemaker — Class II medical device recall Z-2000-2021
Ongoing recall by Boston Scientific Corporation, reported 2021-07-14. Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become e
| Recall number | Z-2000-2021 |
|---|---|
| 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 | 2021-06-03 |
| Classified | 2021-07-02 |
| Reported by FDA | 2021-07-14 |
| Quantity | 70,074 units |
| Serial numbers | 03901, 100003, 100006, 100008, 100009, 100010, 100012, 100013, 100015, 100016, 100017, 100018, 100019, 100021, 100022, 100023, 100026, 100029, 100030, 100031, 100033, 100034, 100035, 100036, 100039 and 475 more |
Product
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Reason for recall
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
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-2000-2021. 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.