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

Class I Recall Announced On Cardiosave Cardiac Assist Devices After Patient Death

 
• By Elizabeth Orr

The recall, which is related to the risk fluid leaks may make the pumps shut down during use, comes only a few months after battery packs used in the pumps were recalled.

The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) are being recalled due to reports that fluid leaks may cause the pumps to fail, the US Food and Drug Administration announced on 16 December.

The IABPs, which are manufactured and distributed by Getinge AB/Datascope/Maquet, are cardiac assist devices used during surgery and to treat patients experiencing heart failure. According to the FDA, the class I recall follows 71 known incidents of fluid leaks and one related death

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

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
• By Brian Bossetta

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 
• By Brian Bossetta

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

Makary Proposes Combined Adverse Event Reporting Systems In Megyn Kelly Interview

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 
• By Brian Bossetta

The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.

More from Policy & Regulation

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.