In October 2013, Medtronic Inc. allegedly began notifying its distributors, and the hospitals that use its products, of potential problems with certain lots of its guidewires. At that time, the Medtronic recall of guidewires notified interested parties that certain lots of these medical devices could have potentially serious defects and that, accordingly, the devices should be shipped back to the company for replacement.
Which Medtronic Guidewires Were Recalled?
Guidewires included in the recall were reportedly designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. Approximately 14,900 guidewires from 181 lots of the following products were recalled:
- 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
The affected lots were allegedly produced since mid-April 2013 and distribution reportedly stopped in mid to late October of 2013.
What Has the FDA Said About the Medtronic Recall of Guidewires
While the Medtronic recall was voluntary, the FDA has classified the recall as a Class I recall. That is the most serious classification the FDA can issue and it only occurs when the FDA determines that there is a reasonable probability that use of the product could result in serious adverse health consequences or even death.
At least one patient has reportedly suffered cardiac arrest because the coating on one of the effected guidewires came off—he was resuscitated. Our Louisville Medtronic injury lawyers extend our best wishes for a full and speedy recovery to the person was reported to be injured by a Medtronic guidewire and to anyone else who may have been hurt.