FDA places recall on Medtronic guidewires
Candace Stuart | November 17, 2013 | Cardiovascular Business | Interventional Cardiology

The FDA issued a Class I recall on Medtronic guidewires used in PCIs and in the placement of left ventricular leads for cardiac rhythm devices.

Minneapolis-based Medtronic is notifying hospitals and distributors that the coating on the surface of some models of guidewires may delaminate and detach. The company said it received some complaints, including one that involved patient injury. It advised customers to quarantine the recalled guidewires and return them to the company for replacement or credit.

The affected guidewires were manufactured after mid-April 2013 under the following product lines:

  • Cougar nitinol workhorse guidewire
  • Cougar steerable guidewire
  • Zinger stainless steel workhorse guidewire
  • Zinger steerable guidewire
  • Thunder extra-support guidewire
  • Thunder steerable guidewire
  • ProVia crossing guidewire
  • Attain Hybrid guidewire

Candace Stuart, Contributor

Related Content

Cardiologists make history, perform first-ever transcaval TAVR for pure aortic regurgitation
Q&A: Interventional cardiologist details key breakthroughs in tricuspid valve replacement and repair
Boston Scientific recalls premixed embolic agent after two deaths
New cardiac imaging strategy could reduce ICA, PCI rates
Inter-atrial shunt in RELIEVE-HF improves symptoms in HFrEF, but not HFpEF
FDA grants new imaging tool for CTO interventions its breakthrough device designation

Around the web

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

Radiology Business
Philips launches new AI-enabled CT scanner aimed at cardiology at ECR 2024

Philips introduced a new CT system at ECR aimed at the rapidly growing cardiac CT market, incorporating numerous AI features to optimize workflow and image quality.

Design by Adaptive Theme
Trimed Popup
Trimed Popup