Abiomed recalled 71 Automated Impella Controllers on August 20, 2025. The devices may fail to perform correctly, leading to pump stoppage. Healthcare providers and patients must stop using these devices immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recall affects the following product codes: 0042-0000-US, 0042-0000-US-L, 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, and 0042-0000-UK-L. The devices were distributed in the US and internationally, including Canada, Germany, Great Britain, Italy, Netherlands, and Norway.
The Automated Impella Controllers may experience decreased performance or complete pump failure. This malfunction can trigger alarms indicating an Impella Failure or Impella Stopped Controller Failure.
No specific incidents or injuries have been reported related to this recall. However, the potential for device malfunction poses serious health risks.
Patients and healthcare providers should cease use of the affected devices immediately. Contact Abiomed, Inc. or your healthcare provider for further instructions and follow the manufacturer’s recall guidance.
For further information, contact Abiomed at [phone number not provided]. Visit the FDA website for details on the recall.
Get instant alerts for recalls that affect you. Free forever.
Glenmark Pharmaceuticals recalled nearly 97,000 packs of Ondansetron Orally Disintegrating Tablets on December 30, 2025. Defective blister packs may not fully seal, leading to tablets falling out. Consumers should stop using the product immediately and contact healthcare providers.
Novo Nordisk recalled Wegovy (semaglutide) injections on December 19, 2025, after discovering hair in prefilled syringes. The contamination poses a serious hazard to consumers. The recall affects all units distributed nationwide.
Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.
Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.
CareFusion 213, LLC recalled 106,400 units of ChloraPrep Triple Swabsticks on December 17, 2025. The recall occurred due to a lack of assurance of sterility. Consumers must stop using the product immediately and contact CareFusion for guidance.
Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.
Merck Sharp & Dohme LLC recalled 3 single-dose kits of Emend (aprepitant) on December 12, 2025. The recall stems from the potential presence of metal particulates in the medication. Consumers should immediately stop using the product and contact their healthcare provider for guidance.
Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.