The FDA Have Issued a Highly Serious Class 1 Recall of Medtronic Devices Which Have been Used in Nearly 15000 procedures

The FDA Have Issued a Highly Serious Class 1 Recall of Medtronic Devices Which Have been Used in Nearly 15000 procedures

The US safety body The Foods and Drugs Agency (FDA) have reported that some patients have complained about guidewires devices which are used in heart procedures.
The FDA said that some of the defects are life threatening and could result in serious injury or death.
Medtronic released a statement where they confirmed that they had started to alert hospitals and distributors that some of the coating on some of the guidewires could delaminate and detach. Medtronic want the affected units to be withdrawn from use and returned to the company.
The Guidewires are used as guide devices including stents through arteries. There is a chance that in some of the devices the coating could detach on the guidewires could result in bloods clots and blocked blood vessels. This could cause strokes and heart attacks and may lead to irreversible damage to vital organs.
There have been four known cases of problems that have been reported to Medtronic. One of the patients went into cardiac arrest.
The recall has been catergorised as a Class 1 recall by the FDA.
“Class I recall: 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.”
There are around 15000 guidewires that are affected by the recall these including specific lots which were made after mid-April 2013:
Cougar nitinol workhorse guidewire
Cougar steerable guidewire
Zinger stainless stell workhorse guidewire
Zinger steerable guidewire
Thunder steerable guidewire
ProVia crossing guidewire
Attain Hybrid guide wire
Read more information on the Medtronic website.

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