The FDA has classified the Medtronic cardiac “guidewires” recall as a Class 1, the most serious category.
Medtronic issued a voluntary recall of the “guidewires,” the wire connectors used to connect cardiac devices that help regulate heartbeat and other functions and facilitate heart surgery because the coating on the wire may disintegrate causing the wire to detach and put the patient at risk for injury or death.
The company issued a recall letter to doctors on October 21, 2013, “Urgent Medical Device Recall, Medtronic Interventional Wires and ATTAIN HYBRID guide wires.”
Injured patients or the families of patients who have died are urged to contact a competent law firm with medical device liability experience. Harman Law LLC is investigating the device’s side effects on behalf of patients. The recalled guidewires are being investigated as potential triggers for heart attack, stroke or other injury. The guidewires are used with an internal heart pacemaker, monitor, or other implanted device or undergone heart surgery that required intervention using one of these wires.
The recalled guidewires are:
- Cougar Nitinol Workhorse Guidewire
- Cougar Steerable Guide wire
- Zinger Stainless Steel Workhorse Guidewire
- Zinger Steerable Guidewire
- Thunder Extra-Support Guidewire
- Thunder Stet Delivery System
- ProVia Crossing Guidewire
- Attain Hybrid Guidewire
These recalled products were manufactured from April, 2013 through September, 2013 and distributed from May, 2013 through October, 2013.
According to the FDA, Class 1 recall is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Specific side effects mentioned in media reports and FDA adverse event reporting include:
- Heart attack
- Stroke
- Blood Clots
- Death
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