Implantable cardioverter defibrillators — Class I medical device recall Z-1305-2021
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2021-04-07, distributed nationwide. A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recomm
| Recall number | Z-1305-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2021-02-03 |
| Classified | 2021-03-26 |
| Reported by FDA | 2021-04-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BG, BH, BR, BS, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, GY, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JM, JP, KE, KR, KW, KY, LB, LK, LT, LU, LV, MA, MT, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, ZA |
| Quantity | 290,086 units |
| UPC / GTIN / UDI-DI | 00643169017887, 00643169017894, 00643169017900, 00643169017917, 00643169017924, 00643169017931, 00643169017948, 00643169017955, 00643169018020, 00643169018037, 00643169018044, 00643169018051, 00643169018068, 00643169018075, 00643169018082, 00643169018099, 00643169314092, 00643169314108, 00643169314115, 00643169314122, 00643169314139, 00643169314146, 00643169314153, 00643169314160, 00643169314177 and 48 more |
| Serial numbers | DDBB1D1, DVAB1D1 |
Product
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
Reason for recall
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
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-1305-2021. 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.