12/23/2020
Attention all. The medical device below has been recalled by the FDA. It is a level 1 recall meaning it is the most serious type of recall and the device carries with it a high risk of injury or death.
Please follow link below re: the recall instructions. In the unfortunate event you have been injured, or lost a loved one, due to this flawed device please contact our defective medical device attorneys handling product liability lawsuits.
We offer free case reviews and charge no fees if we cannot obtain benefits and compensation for you and your 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.
Recalled Products
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
Device Use
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.
Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select)
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.
There have been 57 complaints about this device issue and 14 reports of serious injuries. There have been no reported deaths.
Who May be Affected
Health care providers using the affected Cook Medical introducers
Patients who have procedures with the affected Cook Medical introducers
What to Do
On November 24, 2020, Cook Medical sent an Urgent Medical Device Recall notification letter to all affected customers letting them know the company is removing all devices potentially affected from the market.
The letter also provided the following instructions for customers:
Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form.
Share the Urgent Medical Device Recall notification 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.
Contact Information
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 [email protected].
Additional Resources
Medical Device Recall Database Entry
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.
Recalled Product:
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
Device Use
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.
Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select)
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.
There have been 57 complaints about this device issue and 14 reports of serious injuries. There have been no reported deaths.
Who May be Affected
Health care providers using the affected Cook Medical introducers
Patients who have procedures with the affected Cook Medical introducers
What to Do
On November 24, 2020, Cook Medical sent an Urgent Medical Device Recall notification letter to all affected customers letting them know the company is removing all devices potentially affected from the market.
The letter also provided the following instructions for customers:
Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form.
Share the Urgent Medical Device Recall notification 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.
Contact Information
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 [email protected].
Additional Resources
Medical Device Recall Database Entry
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.
Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers are catheters that help insert other medical devices used for therapy or diagnosis into
