Medtronic, Inc. initially began notifying hospitals and distributors worldwide in October 2013 that some models of its guidewires used in cardiac procedures could lose the coating on their surface resulting in the detachment and delaminating of the guidewires. If the guidewires fail during or after the procedure, serious injury or death to the patient can result. The notification from Medtronic requested that all potentially affected units be quarantined immediately, and returned to the company as soon as possible for replacement.
However, in light of this serious issue, the FDA recently classified Medtronic, Inc.’s “voluntary field action” into a Class I Recall. A Class I Recall is defined as a situation where the use of or exposure to a product will cause serious injury or death to a person.
Click here to read the full article: Medtronic Guidewires Draw Class I Recall due to Deadly Risk
The FDA has taken the next step by alerting both patients and providers of the risk. One hundred and eighty-one lots involving 14,896 guidewires have been recalled. They include 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 guidewire
Medtronic, Inc., based in Minneapolis, Minnesota, was previously involved in massive drug litigation involving their Medtronic implantable defibrillators products that caused injuries to many of their consumers.
If you have one of these eight product lines, contact your physician immediately.
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