ANSM Drug & Device Safety Alerts

Impella AIC consoles with software <10.1 and Impella 5.5 first-gen safety alert

The ANSM has been informed of a safety action by Abiomed concerning Impella AIC consoles with software versions prior to 10.1, when used with first-generation Impella 5.5 ventricular assist devices. Healthcare providers using these devices have received specific instructions from Abiomed.

Neonatal incubator safety alert: Lifetherm 2000

The ANSM has issued a safety alert regarding the Lifetherm 2000 neonatal incubator manufactured by Löwenstein Medical GmbH & Co. KG. The alert, registered under number R2607231, concerns a specific healthcare facility and includes a letter from the manufacturer detailing the safety action.

ANSM Safety Alert for Manosplint Cushionfoam Medical Device

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Manosplint Cushionfoam medical device, identified by safety action number R2606620. This alert concerns a safety action initiated by the manufacturer, Kinetec SAS.

Spinal Plug Safety Alert for Pharmacies

The French ANSM has been informed of a lot recall action for spinal plugs (Airplug T10-T12) by Groupe Lépine, registered under action number R2607057. Pharmacies are directed to consult the provided letter from the manufacturer for details.

Safety alert for DermaGenius 3.0 reagent

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the DermaGenius 3.0 Complete Multiplex real-time PCR reagent. This alert, registered under number R2607183, informs medical biology analysis laboratories of a security action implemented by PathoNostics.

ANSM Safety Information: Mobile Hoist and Bath Elevator

The French National Agency for Medicines and Health Products Safety (ANSM) has issued safety information regarding a mobile hoist and bath elevator from Mangar International. This notice, registered under number R2607055, alerts home healthcare providers and retailers to a safety action implemented by the manufacturer.

ArjoHuntleigh Tenor Mobile Hoist Safety Alert

The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced a product recall for the ArjoHuntleigh Tenor mobile hoist. This action, registered under number R2606757, is being implemented by the manufacturer ArjoHuntleigh AB.