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Defective Catheter Recall

Various medical device makers have initiated catheter recalls after receiving reports of serious health complications potentially linked to catheter device failure. Among the issues cited in the recalls were catheter separation and breakage, possibly leading to device fragments being caught in the patient's soft tissues.


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Catheter Device Failure

Catheter Recall Catheters are used to administer medications, inject contrast dye, or remove blood clots and bodily fluids from a patient. They are usually inserted into the body via a cavity, duct or blood vessel.

Urgent medical recalls have now been announced for a variety of catheters due to the potential for catheter fracture or separation. In some cases, the catheter may not work as expected. In other cases, however, fragments of the catheter could become embedded in the patient, causing the potential for serious injury or death. Medical professionals have been urged to immediately stop using the affected items.

Cook Catheter Recall

On April 15, 2016, Cook Medical voluntarily recalled more than four million catheters that used Beacon Tip technology. According to Cook Medical, those catheters can experience polymer degradation of the tip, which can result in the tip fracturing and/or separating. As of the time of the recall, Cook Medical was aware of 30 medical device reports concerning tip fracture or separation.

Among the potential adverse events linked to catheter polymer degradation: loss of device function; separation of device requiring medical intervention; and complications including device fragments in the vascular system, genitourinary system, or other soft tissues. Ultimately, catheter fragments could wind up embolizing the heart or lungs. Factors that may contribute to polymer degradation include storage temperature and humidity.

All lots of Cook Medical catheters that used the Beacon Tip technology were recalled. The FDA classified the recall a Class 1 recall, indicating use of the devices could cause serious injuries or death.

The recall initiated in 2015, when Cook Medical announced a lot-specific recall. At that time, the company had received 26 complaints linked to catheter splitting or separation.

Stryker Sustainability Solutions Catheter Recall

On June 1, 2016, Stryker Sustainability Solutions initiated a recall of Angiodynamics Soft Vu Omni Flush Angiographic Catheters, due to reports of separation of the tip, which could cause loss of device function and serious medical complications.

"Tip separation can also lead to internal organ injury and cause stroke, kidney failure and intestinal failure among other serious adverse health consequences, including death," the company noted. As with the Cook Medical recall, the Stryker Sustainability Solutions recall was classified by the FDA as a Class 1 recall, the most serious type of recall.

Boston Scientific Catheter Recall

On March 22, 2016, Boston Scientific announced a recall of its Fetch 2 Aspiration Catheter due to reports the catheter shaft could break at various points along the device, which could result in additional medical procedures, serious injury, or death of the patient. The company advised all affected customers to discontinue use of the recalled products immediately. The FDA categorized the recall a Class 1 recall.

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The Recalled Fetch 2 Aspiration Catheter Received FDA 510(k) Clearance
The Recalled Fetch 2 Aspiration Catheter Received FDA 510(k) Clearance
October 8, 2017
Washington, DC: When the Fetch 2 Aspiration Catheter was originally launched by Bayer Medical Care Inc., (Bayer), there was no shortage of platitudes which, sometime later presented as a stark contrast to the eventual global recall that resulted in many a lawsuit amidst allegations of defective catheters causing injury [READ MORE]

Why so many Catheters Recalled?
Why so many Catheters Recalled?
September 27, 2017
Santa Cruz, CA: Another catheter was recalled last week, and this one got a Class 1 recall category, meaning the most serious kind [READ MORE]

Mother and Nurses Blame Catheter for Baby’s Death
Mother and Nurses Blame Catheter for Baby’s Death
August 3, 2017
Worcester, MA “The nurses in the hospital explained to me that baby Amber’s infection was due to the catheter. And my daughter’s autopsy states that infection was the cause of death,” says Tara [READ MORE]


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