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 bradyarrhy
Check against the official notice below — it lists the full affected range.
Medtronic is recalling approximately 21,111 Amplia MRI and Claria MRI CRT-D implantable cardiac devices distributed in the United States and multiple other countries. During internal testing, the company discovered that the AdaptivCRT (aCRT) feature on these devices may appear to be enabled when it is actually not active. This discrepancy between the displayed status and the actual operational state of the feature was identified during next-generation product development testing.
The affected devices were manufactured and released as of November 22, 2016, and are identified by specific serial numbers beginning with RPA200003H through RPA200060H. The recall affects 13,198 devices in the United States and 7,913 devices internationally, including distribution to Australia, Japan, France, Germany, South Africa, and numerous other countries. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US: All states in USA including DC & PR. OUS: Australia, Finland, Japan, Saudi Arabia, Austria, France, Korea,Singapore, Bangladesh, Germany, Luxembourg, South Africa, Belgium, Greece, Malaysia, Spain, Brunei Darussalam, Guadeloupe, Netherlands, Sweden, Cayman Islands, Hong Kong, New Zealand, Switzerland, Chile, India, Norway, Thailand, Cyprus, Iran, Poland, Turkey, Denmark, Ireland, Portugal, Uni Quantity: 21,111 ( 13,198 US; 7,913 OUS). Lot/code info: 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 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 00643
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.