Medtronic Cardiac Guidewire Recall Deemed a Class I by FDANov 18, 2013
Medical device maker Medtronic Inc. just announced that its recent field action regarding certain cardiac guidewires has been deemed a Class I recall by the U.S. Food and Drug Administration (FDA). The defective now-recalled guidewires are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices.
When the agency deems a firm’s action a Class I recall, that means that the situation involves a “reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death,” the agency indicates. Medtronic’s field action was deemed a Class I following an internal agency investigation that was prompted by numerous complaints, including one injury.
The week of October 21, Medtronic began issuing global notifications to hospitals and distributors that some guidewire models from recent lots have the potential for the coating on their surface to delaminate and detach. The notification also requests that all potentially affected units be immediately quarantined and returned to Medtronic as soon as possible for credit and replacement. According to the FDA, Medtronic has also taken steps to prevent future shipments of the recalled guidewires and has notified regulatory agencies worldwide, as appropriate.
The recall includes specific lots from the following eight product lines 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
In related news, an Indiana appeals court ruled that Medtronic cannot use so-called “preemption” to avoid a negligence lawsuit that was filed over a failed Transvene defibrillator lead. Preemption is legal concept that a number of medical device makers have used in liability lawsuits filed over FDA-approved devices, MassDevice.com previously reported.
In this case, the Court of Appeals of Indiana denied Medtronic’s bid for summary judgment; the device maker argued that federal preemption laws barred the negligence claim against it, according to MassDevice.com. In 1997, the plaintiff was implanted with a Medtronic defibrillator and a Transvene lead, court records indicate. The defibrillator was upgraded in 2004; the lead remained in place. Nine episodes of random short V-V intervals—false positives in which the lead senses electrical activity that does not involve cardiac activity—took place, according to court documents.
On December 7, 2006, surgery was undertaken to replace the defibrillator; however, the surgeon did not replace the Transvene lead after an on-site Medtronic representative and two technical services representatives (contacted by telephone) advised the surgeon not to be concerned with the short V-V intervals, court documents indicate. Appeals court documents indicate that lead testing did not reveal the issue, according to MassDevice.com.
According to court documents, the physician asked a number of questions about the short V-V intervals, including if this issue indicated that lead failure was occurring; the Medtronic technical service representative said, “Don’t worry about that; it doesn’t mean anything…. I don’t think that’s a problem.” The plaintiff died less than one month later, “following an incident of ventricular tachycardia on December 31, 2006. Testing revealed 361 short V-V intervals of his defibrillator from December 14, 2006 through December 31, 2006,” also according to court documents, MassDevice.com reported.