Cook Medical recalled its Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers due to Separation Risk Causing of Organ Damage, Vascular Injury, Hemorrhages, and Fatalities.
Injury related hemorrhages
FDA/COOK MEDICAL – December 24, 2020 – According to a recall notice from the U.S. Food and Drug Administration (FDA), Cook Medical has initiated a worldwide recall of its Flexor® Check-Flo® Introducer Set and its Flexor® Tuohy-Borst Side-Arm Introducer Set (Shuttle Select) due to reports of surgical complications caused by a separation defect that may lead to vessel injury-related hemorrhages, and embolization occluding blood flow to vital organs causing organ damage, and fatalities. The FDA has classified this recall as a Class I recall. Class I recalls are the most severe recall classification used by the FDA. The Class I recall designation is reserved only for recalls that involve products, medications, or medical devices that can cause serious injuries or death.
What Are Cook Medical Introducers Used For?
The Flexor® Check-Flo® Introducer Set and Flexor® Tuohy-Borst Side-Arm Introducer Set (Shuttle Select) are sterile, single-use medical devices used to “introduce balloon, closed- and non-tapered-end catheters, or other diagnostic and interventional devices” during medical and surgical procedures. The Cook Medical Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) are Intravenous Catheters (also known as IV Catheters) that are designed to help insert other medical devices into blood vessels. The intravenous catheters introducer sets help the medical devices aid in providing the patient with therapy or aid in medical diagnosis procedures. These catheter introducer sets are not used in coronary and neuro vasculature procedures. The catheter introducers have a coated shaft, a dilator, a valve, and special measurement markers that appear on x-rays.
Why are the Cook Medical Introducer Sets Being Recalled?
Cook Medical is recalling its Flexor Check-Flo Introducer Set and its Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) Sets due to an increased risk of a dangerous separation defect at the proximal bond site. If the introducer separates at the proximal bond site during a surgical or medical procedure, the patient could suffer dangerous vascular hemorrhages, organ damage due to blood blockage, or death. In addition, the patient could face other complications during any emergent intervention procedures necessary to retrieve the separated segment.
Cook Medical has received over 57 complaints of adverse events involving its Flexor Check-Flo Introducers and its Flexor Tuohy-Borst Side-Arm Introducers; 14 of the adverse events involved severe injuries.
The recall notice has been issued to all health care providers who have purchased and used the affected Cook Medical introducers. All patients who had therapeutic or diagnostic procedures with the recalled Cook Medical introducers will also be notified. The initial “Urgent Medical Device Recall” notification letter was sent on November 24, 2020. The notification letter was sent to all affected customers and announced that Cook Medical is removing all affected devices from the market.
The initial “Urgent Medical Device Recall” notification letter also gave the following directions for customers:
- Return the recalled introducer kits to Cook Medical along with the Acknowledgement and Receipt Form.
- Distribute the “Urgent Medical Device Recall notification letter” with staff all the way down to the user level, within your organization, and with any other organization the recalled introducer kits have been transferred.
- Promptly report all adverse events to Cook Medical Customer Relations.
A copy of the November 25, 2020, “Urgent Field Safety Notice” for Cook Medical’s Flexor® Check-Flo® Introducer and Flexor® Tuohy-Borst Side-Arm Introducer (Shuttle Select®) may be read here.
Patients and health care professionals may report any quality issues or adverse reactions they have experienced with these medical devices to the FDA’s Safety Information and Adverse Event Reporting Program (MedWatch) using an online form, regular mail, or FAX found at MedWatch.
For a complete list of Flexor Check-Flo Introducers Catalog Numbers, Lot Numbers, and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) Catalog numbers, click here to view on the FDA’s recall notice.
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