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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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DEFECTIVE CATHETER LEGAL ARTICLES AND INTERVIEWS

Catheter Injury Lawsuits following Catheter Recalls
Catheter Injury Lawsuits following Catheter Recalls Dallas, TX: In the wake of more than four million catheter recalls over the past year by numerous medical device manufacturers, dozens of patients have reported injuries and two wrongful death lawsuits have been filed due to broken catheters [READ MORE]

Will Federal Deregulation make it Easier for Plaintiffs to Sue over Defective Catheters?
Will Federal Deregulation make it Easier for Plaintiffs to Sue over Defective Catheters? Washington, DC: We are just a few days beyond the one-year anniversary of the issuance, by the US Food and Drug Administration (FDA), of a Class 1 designation to the recall of the Fetch 2 Aspiration Catheter by medical device manufacturer Boston Scientific. The voluntary recall was triggered by the manufacturer the previous month, on March 22, 2016 [READ MORE]

FDA Issues Recall on Medtronic Implantable Pain Pumps
FDA Issues Recall on Medtronic Implantable Pain Pumps Silver Spring, MD: Six months after Medtronic issued a voluntary recall on certain potentially defective catheters, the Federal Drug Administration has announced an update on a previous recall on two of Medtronic's implantable drug pumps [READ MORE]



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