Medtronic Inc., Cardiac Rhythm and Heart Failure: Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan

Is my product affected?

Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan

• UPC 00643169543362

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Inc. is recalling approximately 25,025 cardiac rhythm management devices across three product lines: Amplia MRI Quad CRT-D SureScan, Claria MRI Quad CRT-D SureScan, and Compia MRI Quad CRT-D SureScan. The recall was initiated after Medtronic detected an unexpected transient mode switch behavior during systems testing of these MRI-compatible devices. The affected devices were distributed nationwide in the United States and internationally to countries including Australia, Canada, France, Germany, India, Japan, and numerous others.

The record does not specify a remedy for consumers who have received these devices.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.

Details from the source

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. Distribution: USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam Greece Jordan Oman Canada Guadeloupe Kuwait Poland Cayman Islands Hong Kong Lebanon Portugal Cyprus Hungary Luxembourg Denmark India Macedonia Reunion Dominican Republic Iran Malaysia Singa Quantity: 25,025 ( 16,369 US; 8,656 OUS) Lot/code info: UPN Lot Serial # 00643169543362 RPA200003H 00643169543362 RPA200004H 00643169543362 RPA200005H 00643169543362 RPA200006H 00643169543362 RPA200007H 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 RPA200026H 00643169543362 RPA200027H 00643169543362 RPA200028H 00643169543362 RPA200029H 00643169543362 RPA200030H 00643169543362 RPA200031H 00643169543362 RPA200032H 00643169543362 RPA200033H 00643169543362 RPA200034H 00643169543362 RPA200035H 00643169543362 RPA200036H 00643169543362 RPA200037H 00643169543362 RPA200038H 00643169543362 RPA200039H 00643169543362 RPA200040H 00643169543362 RPA200041H 00643169543362 RPA200042H 00643169543362 RPA200043H 00643169543362 RPA200044H 00643169543362 RPA200045H 00643169543362 RPA200046H 00643169543362 RPA200047H 00643169543362 RPA200048H 00643169543362 RPA200049H 00643169543362 RPA200050H 00643169543362 RPA200051H 00643169543362 RPA200052H 00643169543362 RPA200053H 00643169543362 RPA200054H 00643169543362 RPA200055H 00643169543362 RPA200056H 00643169543362 RPA200057H 00643169543362 RPA200058H 00643169543362 RPA200059H 00643169543362 RPA200060H 0

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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