ASSURITY Pulse Generator REF PM**** SN ********* ST — Class I medical device recall Z-1530-2021
Ongoing recall by St. Jude Medical, Cardian Rhythm Management Division, reported 2021-05-19, distributed nationwide. Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacema
| Recall number | Z-1530-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Cardian Rhythm Management Division, Sylmar, CA, United States |
| Recall initiated | 2021-03-15 |
| Classified | 2021-05-07 |
| Reported by FDA | 2021-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, CA, CH, CL, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GT, HK, HU, IE, IN, IT, JO, JP, KR, LB, LK, LT, LU, MA, MX, MY, NL, NO, NP, NZ, PA, PE, PK, PL, PT, PY, QA, RO, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05414734507066, 05414734507073, 05414734507097, 05414734509572, 05414734509589 |
| Serial numbers | 7628828, 7629513, 7629762, 7630106, 7630232, 7630233, 7630235, 7630364, 7630367, 7630369, 7630370, 7630371, 7630372, 7630383, 7630394, 7630397, 7630398, 7630399, 7630400, 7630401, 7630402, 7630403, 7630413, 7630421, 7630428 and 475 more |
Product
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Reason for recall
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
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-1530-2021. 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.