1. Medtech Insight

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.

Medtronic HQ sign
• Source: Shutterstock

Medtronic is recalling two models of its Pipeline Vantage embolization device after learning of 17 injuries and four deaths linked to the products, the US Food and Drug Administration announced Tuesday. The agency has deemed the recall Class I, its highest-risk designation.

The recall for 027 is a product removal and for 021 is an update to the instructions for use.

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 Medtech Insight

GE HealthCare Launches Intraoperative Ultrasound Product Series: bkActiv S

 
• By Natasha Barrow

GE HealthCare launches bkActiv S series – part of the bkPortfolio family of Active Imaging systems.

India’s MedTech Future Hinges On Regulatory Reform And Global Alignment: MTaI’s Pavan Choudary

 
• By Shubham Singh

In this in-depth interview with Medtech Insight, Pavan Choudary unpacks the implications of recent free trade agreements (FTAs) such as India’s with the UK, the potential fallout from new US tariffs on Indian device exports, and the pressing need for regulatory harmonization.

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By Ashley Yeo

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

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.