FDA Device recall Z-0962-2017
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantabl…
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantabl… by Medtronic Cardiac Rhythm And Heart Failure, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0962-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-09 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers of AMPLIA & CLARIA Released from Manufacturing as of 22-Nov-2016 UPN Serial 00643169543362 RPA200003H…Serial Numbers of AMPLIA & CLARIA Released from Manufacturing as of 22-Nov-2016 UPN Serial 00643169543362 RPA200003H 00643169543362 RPA200004H 00643169543362 RPA200005H 00643169543362 RPA200006H 00643169543362 RPA200008H 00643169543362 RPA200009H 00643169543362 RPA200010H 00643169543362 RPA200011H 00643169543362 RPA200012H 00643169543362 RPA200013H 00643169543362 RPA200014H 00643169543362 RPA200015H 00643169543362 RPA200016H 00643169543362 RPA200017H 00643169543362 RPA200018H 00643169543362 RPA200019H 00643169543362 RPA200021H 00643169543362 RPA200022H 00643169543362 RPA200023H 00643169543362 RPA200024H 00643169543362 RPA200025H 00643169543362 RPA200027H 00643169543362 RPA200028H 00643169543362 RPA200029H 00643169543362 RPA200030H 00643169543362 RPA200031H 00643169543362 RPA200032H 00643169543362 RPA200033H 00643169543362 RPA200034H 00643169543362 RPA200035H 00643169543362 RPA200036H 00643169543362 RPA200037H 00643169543362 RPA200039H 00643169543362 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0962-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.