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Latest Defective Catheter Takes Its Place in Long Line of FDA Recalls

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Silver Spring, MDWhen it comes to defective catheters causing injury, Bard Peripheral Vascular's recall of its Halo One Thin-Walled Guiding Sheath is the latest in a long line of catheter recalls that include the Boston Scientific Corp. Fetch 2 Aspiration Catheter and Cook Medical's Shuttle Select Slip-Catheter and Beacon catheters.

Catheters, which are devices inserted into a blood vessel through a small puncture in the skin, are used for a wide range of procedures, including administering medication, injecting contrast dye or removing small blood clots from veins and arteries.

In recent years, though, manufacturers have issued multiple defective catheter safety recalls of numerous catheter devices mainly due to reports of breakage and migration.

On January 10, 2017, Bard Peripheral Vascular recalled the Halo One Thin-Walled Guiding Sheath, a catheter device used to guide or place interventional and diagnostic devices into veins and arteries on a patient's leg. A few weeks later, the Federal Drug Administration (FDA) issued a January 30 safety alert, identifying the Halo recall as a Class I, the most serious type of recall.

According to the FDA safety alert, Bard is recalling the device because the sheath body may separate from the sheath hub while removing the device from the patient's leg. The sheath may also kink and its tip can become damaged during the procedure.

"The use of affected sheaths may result in prolonged procedure times and additional surgical intervention to remove detached components from the patient," stated the alert. "The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding and death."

Other brands of catheters have also been recalled over the past two years due to their potential to cause life-threatening injuries. In April 2016, the FDA issued a Class 1 recall of the Fetch 2 Aspiration Catheter, manufactured by Boston Scientific Corp.

The recall came after reports of breakage along various points of the device before or during procedures, which could cause pieces of the catheter to block blood supply to the heart or blood vessels, resulting in the need for additional medical procedures, patient injury or death.

"There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter," Boston Scientific announced in the news release of its recall. "While unreported, the most severe potential outcome of this breakage is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically."

In October 2015, Cook Medical also recalled 4.1 million Beacon Tip Angiographic Catheters after the devices were found to experience tip splitting or separation, which could lead to blocked blood flow to organs. Cook later expanded its original recall to include several additional catheter devices, including the Shuttle-Select Slip-Cath and Beacon Tip Catheter.


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