Reported Jan 18, 2017 · Terminated
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D…
Medtronic Inc., Cardiac Rhythm and Heart Failure
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure · 8200 Coral Sea St NE · Mounds View, MN · 55112-4391
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers of AMPLIA & CLARIA Released from Manufacturing as of 22-Nov-2016 UPN Serial
2,408 of 2,408 codes
00643169543362RPA200003H00643169543362RPA200004H00643169543362RPA200005H00643169543362RPA200006H00643169543362RPA200008H00643169543362RPA200009H00643169543362RPA200010H00643169543362RPA200011H00643169543362RPA200012H00643169543362RPA200013H00643169543362RPA200014H00643169543362RPA200015H00643169543362RPA200016H00643169543362RPA200017H00643169543362RPA200018H00643169543362RPA200019H00643169543362RPA200021H00643169543362RPA200022H00643169543362RPA200023H00643169543362RPA200024H00643169543362RPA200025H00643169543362RPA200027H00643169543362RPA200028H00643169543362RPA200029H00643169543362RPA200030H00643169543362RPA200031H00643169543362RPA200032H00643169543362RPA200033H00643169543362RPA200034H00643169543362RPA200035H
- Serial Numbers of AMPLIA & CLARIA Released from Manufacturing as of 22-Nov-2016 UPN Serial
- Amount recalled
- 21,111 ( 13,198 US; 7,913 OUS).
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart Failure recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.