Class I Recall For Integra’s CereLink Intracranial Pressure Monitors

The US FDA has labelled a June recall of intracranial pressure monitors from Integra with its most serious designation, class I.

Recall
• Source: Shutterstock

In June, Integra LifeSciences initiated a recall of 388 CereLink intracranial pressure monitors (ICPs) because of reports that readings from the devices were inaccurate. The company also adjusted its quarterly and yearly earnings to reflect the impact of the recall. (Also see "Integra Issues Recall Of Intracranial Pressure Monitors" - Medtech Insight, 25 August, 2022.)

The Food and Drug Administration has now labelled that recall as class I.

More from Regulation

More from Policy & Regulation

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By 

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.