1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Recalls

Recalls For Datascope And Abiomed Designated Class I

 
• By Elizabeth Orr

The US FDA has updated a recall of Datascope Cardiosave IABPs to reflect its class I high-risk status and announced a recall of the labeling for Abiomed’s Impella RP Flex. 

FDA recall text on white notepad paper on blue background.
• Source: Shutterstock

The US Food and Drug Administration released information about two cardiac device recalls on 17 August, including the classification of an ongoing recall of Datascope Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as well as a new recall of the labeling for Abiomed’s Impella RP Flex with SmartAssist.

Both recalls have been designated as class I, the FDA’s highest-risk level.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Recalls

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 
• By Brian Bossetta

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

Additional Death And Injuries Added To 2024 Philips Ventilator Recall

 
• By Brian Bossetta

Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.

J&J’s Ethicon Issues Class I Correction For Echelon Stapler Reloads Amid Lockout Risk

 
• By Shubham Singh

The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

More from Policy & Regulation

FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By Ashley Yeo

In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 
• By Brian Bossetta

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.