12.7.20
By Mike Smith
In late November, Cook Medical began to recall lots of its Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers because of serious risk of injury from device separation when these arterial catheters are being used in surgical and diagnostic procedures. The FDA quickly categorized the action as a Class 1 recall
, which are the most serious and urgent type of recall.
According to the FDA, these 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.
These catheters have an increased chance of separation at a specific bonding point, which could prevent the completion of the intervention and create the very real danger of leaving a part of a medical product inside the patient.
According to the FDA:
- 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.
2020 has been a bad year for arterial catheters with many of the biggest manufacturers in this sector issuing Class I Recalls, many of which were linked to serious injuries and patient deaths. Like this Cook Medical recall, many of these others were due to deployment device failure. See posts here (Abbott Balloons fail to deflate), here (Pipeline Flex), here (SD Biosensor) and here (Stryker Deadly Recall) for more details on the long list of 2020 arterial catheter device recalls.