Eight Product Lines Affected By Announcement

Medical technology firm Medtronic has announced a recall of some of its models of guidewires which are used as part of cardiac devices.

The company has confirmed that following an internal investigation it has been notifying hospitals and worldwide distributors that some models from recent lots have the potential for the coating on the surface to both delaminate and detach.

Medtronic called on all potentially affected units to be quarantined and returned to the company as soon as possible, with the US Food and Drug Administration subsequently classifying the action as a Class I recall.

The eight affected product lines were manufactured after mid-April 2013 and are:

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

Additional information on the specific affected lot numbers is now available from the Medtronic website.

Expert Opinion

Through our work representing victims who have suffered serious health complications as a result of the failure of medical devices, including nearly 300 patients affected by problems with metal-on-metal hip replacements, we have seen the huge difficulties that can be caused by faulty products. <br/> <br/>"We would urge all health authorities and distributors to ensure they act upon this recall and ensure that everything possible is done to prevent the affected lot numbers from being used during treatment. <br/> <br/>"Further to that, it is also important that Medtronic works to ensure that lessons are learned quickly from the problems seen in this case to ensure that the same issues are not repeated in the future. <br/> <br/>"Any issues of this kind undoubtedly raise questions about how faulty or potentially dangerous devices make it onto the wider market, as well as whether more can be done to improve the regular testing and overall regulation of products. <br/> <br/>"We will be following developments in relation to this issue very closely."