Implantable cardioverter defibrillators — Class I medical device recall Z-1306-2021
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-1306-2021 |
|---|---|
| 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 | 238,393 units |
| UPC / GTIN / UDI-DI | 00643169007130, 00643169007147, 00643169007154, 00643169007161, 00643169007178, 00643169007185, 00643169007192, 00643169007208, 00643169007215, 00643169007222, 00643169007239, 00643169017993, 00643169018006, 00643169018013, 00643169217980, 00643169309050, 00643169353756, 00643169353763, 00643169353770, 00643169353787, 00643169353794, 00643169353800, 00643169353886, 00643169353893, 00643169518179 and 30 more |
| Serial numbers | BLF222908H, BLF225347H, BLF225677H, BLF226002H, BLF226006H, BLF226010H, BLF226230H, BLF226318H, BLF226405H, BLF226436H, BLF226747H, BLF227224H, BLF227225H, BLF227236H, BLF227237H, BLF227249H, BLF227454H, BLF227584H, BLF227589H, BLF227676H, BLF227685H, BLF227842H, BLF227887H, BLF228075H, BLF228085H and 475 more |
Product
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
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-1306-2021. 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.