The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Cook Medical Fixed Core Wire Guide
- Affected Models: o Model TSCF-35-260-3
- Manufacturing Dates: August 24, 2020
- Distribution Dates: September 09, 2020
- Devices Recalled in the U.S.: 61
- Date Initiated by Firm: October 14, 2020
The Cook Medical Fixed Core Wire Guide is a curved wire made of stainless steel with non-reactive coating. The device helps insert and guide the placement of medical devices, like catheters and introducer sheaths inside a patient’s body.
Reason for Recall
Cook Medical is recalling the fixed core wire guides because five lots of wire guides dropped onto an unchecked surface during production. This drop could cause the wire guide to bend out of shape or become dirty.
Use of the affected product may cause serious adverse events, including end organ embolization.
There have been no complaints about this device issue. There have been no reported injuries or deaths.
Who May be Affected
- Health care providers using the affected Fixed Core Wire Guides
- Patients who have procedures with the affected Fixed Core Wire Guides
What to Do
On October 22, 2020, Cook Medical sent an Urgent Medical Device Recall notice to all affected customers notifying them the company is removing devices potentially affected from the market and determining the correct actions to prevent a repeat of this issue.
The letter provided the following instructions for customers:
- Examine inventory as soon as possible to find any potentially affected products
- Quarantine any affected product that is unused. Immediately cease all distribution and use of this product.
- Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form included in the letter to receive a product credit.
- Share the Urgent Medical Device Recall letter with appropriate staff, including down to the user level, within the organization, or with any organization where the potentially affected devices have been transferred.
- Immediately report adverse events to Cook Medical Customer Relations.
Consumers with questions about this recall may contact Cook Medical by phone at (800) 457-4500 or (812) 339-2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by emailing CustomerRelationsNA@CookMedical.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.