Medtronic, Inc., just announced that its recent field action involving certain cardiac guidewires has been deemed a Class I recall by the U.S. Food and Drug Administration (FDA). The defective, recalled guidewires are constructed to enable percutaneous coronary interventions or placement of left ventricular leads for cardiac rhythm devices.
When the FDA announces an action has been deemed 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.” Medtronic’s field action was deemed a Class I recall after an internal FDA investigation was prompted by a number of complaints, including one injury.
Medtronic began issuing global notifications to hospitals and distributors during the week of October 21st. The notifications indicate that some guidewire models from recent lots have the potential for the coating on their surface to delaminate and detach and also requested that all potentially affected units be immediately quarantined and returned to Medtronic for credit and replacement. According to the FDA, Medtronic has taken steps to prevent future shipments of the recalled guidewires and has notified regulatory agencies worldwide, as appropriate.
The recall involves certain 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
In related news, an Indiana appeals court recently ruled that Medtronic cannot use so-called “preemption” to avoid a negligence lawsuit that was filed over a failed Transvene defibrillator lead. The legal concept of preemption has been used by a number of medical device makers 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, MassDevice.com reported.
In 1997, the plaintiff was implanted with a Medtronic defibrillator and a Transvene lead, court records indicated. The defibrillator was upgraded in 2004; the lead remained in place. Court records indicate that 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.
December 7, 2006 surgery to replace the defibrillator was conducted; 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.
Court documents also indicate that 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,” also according to court documents. 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,” court documents indicated, MassDevice.com reported.