Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device
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.
Flexor Check-Flo Introducers
• Catalog and Lot numbers: See Full List
• Manufacturing Dates: February 17, 2020 to September 29, 2020
• Distribution Dates: May 23, 2020 to November 17, 2020
• Devices Recalled in the U.S.: 37,326
• Date Initiated by Firm: November 24, 2020
The Cook Medical Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) are catheters that have a coated shaft, a valve, a dilator, and markers that show up on an x-ray. The catheters help insert other medical devices used for therapy or diagnosis into the vessels, except those of the heart and brain, during surgery or other procedures.
Fig. 1: Pictures of the Flexor Check-Flo Introducer and the Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) with a red arrow showing where separation usually happens (proximal bond site).
Reason for Recall
Cook Medical is recalling the Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) because of an increased chance of separation at a specific point (proximal bond site) shown in Figure 1. If the device separates during use, this may lead to life-threatening adverse events.
Use of the affected product may cause serious adverse events, including longer procedure time, another procedure to take out a separated piece, blocking blood flow to vital organs, vessel injury, and bleeding.
Not All Recalls Lead to Litigation
MTNs review of the FDA Maude Adverse Event reporting database and found less than 57 total adverse events reported, related to these recalled devices. In the reported adverse events, the Surgeon was generally able to mitigate the impact of the device defect. There were no reports of death however, there were 14 reports of serious injuries.
These devices are primarily used by Interventional Radiologist. The devices are used in procedures under imaging. Any device failure that might otherwise have caused injury absent real time imaging during the procedure, would generally allow the Surgeon to take immediate corrective action.
MTN does not expect the number of individuals injured by this device will be sufficient to justify a consolidated mass litigation. If your firm receives an inquiry from any individual injured by the defect in these devices, contact our office for more information if you are considering filing an individual plaintiff action.
MTN will keep our readers abreast of any changes in our initial impressions related to this matter.