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

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.

(Shutterstock)

The Food and Drug Administration has issued two early alerts for intravascular imaging systems, one of which has several reported injuries.

The agency’s first alert concerns the PowerPICC intravascular catheter from BD and its subsidiary Bard Access Systems.

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 US FDA

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 
• By Barnaby Pickering

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 
• By Brian Bossetta

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.