FDA Device Recalls

Class IOngoing

Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.

Abiomed, Inc.

Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

August 20, 2025 · DeviceView details →

MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

MAGNETOM Connectom.X. Model Number: 11371480.

MAGNETOM Prisma. Model Number: 10849582.

BIOGRAPH One (DE). Model Number: 11689172.

MAGNETOM Verio Dot. Model Number: 10684333.

Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

Model Number L211 PROPONENT DR SL MRI Pacemaker

Model Number S702, ALTRUA 2 DR SL Pacemaker

Model Number U128, VALITUDE CRT-P EL MRI

Model Number L231, PROPONENT DR EL MRI Pacemaker

Model Number L101, ESSENTIO DR SL Pacemaker

Model Number L209 PROPONENT DR (VDD) SL Pacemaker

Model Number U226, VISIONIST CRT-P EL

PROPONENT SR SL (Model L200)

Model Number U228, VISIONIST CRT-P EL MRI

Model Number L221 PROPONENT DR EL Pacemaker

Model Number L131, ESSENTIO DR EL MRI Pacemaker

ACCOLADE DR EL MRI (Model L331)