Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia… — Class II medical device recall Z-2117-2017
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, reported 2017-05-31, distributed nationwide. An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amp
| Recall number | Z-2117-2017 |
|---|---|
| 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 | 2017-04-12 |
| Classified | 2017-05-19 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2019-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, CA, CY, DE, DK, DO, EG, FI, FR, GR, HK, HU, IE, IL, IN, IR, IT, JO, JP, KW, KY, LB, LU, MA, MY, NL, NO, NZ, OM, PL, PT, SG |
| UPC / GTIN / UDI-DI | 00006431695433, 00643169543362, 00643169543379, 00643169543386, 00643169543393, 00643169543409, 00643169565272 |
| Serial numbers | 00643169543362, RPA20, RPA200003H, RPA200004H, RPA200005H, RPA200006H, RPA200007H, RPA200008H, RPA200009H, RPA200010H, RPA200011H, RPA200012H, RPA200013H, RPA200014H, RPA200015H, RPA200016H, RPA200017H, RPA200018H, RPA200019H, RPA200021H, RPA200022H, RPA200023H, RPA200024H, RPA200025H, RPA200026H and 475 more |
Product
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Reason for recall
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
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-2117-2017. 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.