The FDA recently announced another Class I recall, this time in the cardiovascular space.
The faulty products from Medtronic are guidewires with surface coatings that could potentially divide and detach.
The Fridley, MN-based medical device giant had already initiated voluntary field action related to the guidewires. But the Class I classification from the FDA raises the seriousness of the issue, since it means there is a reasonable probability that the guidewires could cause serious injury or death.
An illustration of a Zinger guidewire from Medtronic's website.
This is not Medtronic’s first recall to reach a Class I level this year.
There was a Class I recall announced over the summer that involved Paradigm infusion sets, designed for use with the company’s Paradigm insulin pumps. Affected models, produced from October of 2001 to June of 2013, had a mechanical issue that could lead to the over- or under-delivery of insulin.
In the case of the guidewires, Medtronic launched an internal investigation after a patient injury and a number of other complaints, the company said Friday.
Medtronic notified hospitals and distributors worldwide of the issue during the week of Oct. 21, requesting that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement.
The guidewires involved in the recall were designed to facilitate percutaneous coronary interventions, coronary angioplasty procedures in which a balloon and often a stent are used to open narrowed arteries of the heart.
The guidewires were also for placement of left ventricular leads for cardiac rhythm devices.
They were part of specific lots from the following eight product lines that were manufactured after mid-April 2013:
• 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 guide wire
