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

A Bad Tip: Boston Scientific Recalls Thousands Of Catheters In Class I Recall

Boston Scientific has recalled more than 6,000 angiographic catheters because the tip can fall off and get stuck in patients, potentially causing serious injury or death. The company says customers should immediately stop using the lots associated with the faulty products and return them.

detailed illustration of a compass with Recall text, eps10 vector

The US Food and Drug Administration issued a high-risk class I recall on 7 April for Boston Scientific Corp.’s Imager II 5F angiographic catheters because the tips can break off and become lodged in blood vessels. The company says it has taken back more than 6,000 of the devices to date.

The catheters are used to deliver contrast agents to blood vessels, including carotid arteries. The FDA says 6,130 catheters have...

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 Compliance

FDA’s Small Business Eligibility Process Gets Update Before New Fiscal Year

 
• By Elizabeth Orr

The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
• By Elizabeth Orr

The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.

More from Policy & Regulation

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

EU/US Trade Deal Raises Questions For Medtech

 
• By Amanda Maxwell

There is still no clarity on how life sciences will be treated in the final agreement.

NICE To Consult On UK Late-Stage Healthtech Assessments

 
• By Ashley Yeo

NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.