Amplia MRI" CRT -D SureScan" — Class II medical device recall Z-0962-2017
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, reported 2017-01-18, distributed in DC, PR. During internal testing conducted as part of next generation product development, it was discovered that the A
| Recall number | Z-0962-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN, United States |
| Recall initiated | 2016-12-09 |
| Classified | 2017-01-07 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2019-07-16 |
| Distributed | DC, PR |
| Countries outside the US | AE, AT, AU, BD, BE, CH, CL, CY, DE, DK, DO, ES, FI, FR, GB, GR, HK, IE, IN, IR, IT, JP, KR, KY, LU, MY, NL, NO, NZ, PL, PT, SA, SE, SG, TH, TR, ZA |
| UPC / GTIN / UDI-DI | 00643169543362, 00643169543379, 00643169543386, 00643169543393, 00643169543416, 00643169543423, 00643169543430, 00643169543447, 00643169705760, 00643169705777, 00643169705784, 00643169705791, 00643169705814, 00643169705821, 00643169705838, 00643169705845 |
| Serial numbers | 00643169543362, 00643169543379, RPA200003H, RPA200004H, RPA200005H, RPA200006H, RPA200008H, RPA200009H, RPA200010H, RPA200011H, RPA200012H, RPA200013H, RPA200014H, RPA200015H, RPA200016H, RPA200017H, RPA200018H, RPA200019H, RPA200021H, RPA200022H, RPA200023H, RPA200024H, RPA200025H, RPA200027H, RPA200028H and 475 more |
Product
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
Reason for recall
During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.
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-0962-2017. 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.