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Defective Catheter Recall
By Heidi Turner
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.
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.
Catheter Device Failure
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.
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.
Cook Catheter Recall
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.
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.
Stryker Sustainability Solutions Catheter Recall
"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.
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.
Boston Scientific Catheter Recall
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