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

One Death Linked To Calyxo Urological System

 
• By Brian Bossetta

The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.

(Shutterstock)

The US FDA has reported one death associated with the CVAC aspiration system and CVAC image processor from Calyxo, which are used to establish a channel during endoscopic urological procedures to treat and remove urinary stones.

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

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.

One Death Linked To Calyxo Urological System

 
• By Brian Bossetta

The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.

Class I Recall On Medtronic Embolization Device After 4 Deaths

 
• By Elizabeth Orr

The company is recalling Pipeline Vantage 021 and 027 models because they pose a higher than normal risk of failing to properly attach to blood vessel walls, which can cause thrombosis, stroke or death. The recall for 027 is a product removal and for 021 is an update to the instructions for use.

More from Policy & Regulation

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 
• By Amanda Maxwell

Ireland’s NSAI reinstated under IVD Regulation designation list

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.