Delamination Risk Prompts FDA Class I Recall of Medtronic’s Guidewires

The US FDA has issued its highest category of  of recall (Class I) for a variety of Medtronic Guidewires, due to the potential for their PTFE coating to part company with the core.

Background

Medtronic steerable guide wires are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Medtronic began notifying hospitals and distributors worldwide in the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. This was based on an internal investigation following a limited number of complaints, including one patient injury.

The notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement, directions repeated in the new FDA notice, which can be found here.

The roll call of Medtronic guidewires affected by this recall is pretty significant. It includes the Cougar Nitinol Workhorse (and steerable) Guidewires, the Zinger Stainless Steel Workhorse (and steerable) Guidewires, the Thunder Extra-Support Guidewire and Thunder Stent Delivery System, the ProVia Crossing Guidewire and the Attain Hybrid Guidewire.

These recalled products were manufactured from April, 2013 through September, 2013 and distributed from May, 2013 through October, 2013.

The potential for PTFE coating to delaminate and detach from the guide wire is clearly a potentially serious matter, given their intended use in the placement of ventricular leads in the coronary vasculature. Because of these potentially serious adverse health consequences the agency has given the action its highest category of recall.

Source: FDA, Medtronic, Inc.

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