Cook Medical recalling 17,000+ catheters and pressure monitoring sets due to tip separation
|Arterial pressure monitoring catheter--Courtesy of Cook Medical|
Cook Medical is recalling 17,827 single-lumen central venous catheters and pressure monitoring sets and trays because of concerns about catheter tip fracture and/or separation. The FDA posted the Bloomington, IN's company's recall on its website, an action it takes from time to time to publicize recalls that are critical to patient safety.
"During an internal inspection, a catheter exhibited the potential for catheter tip fracture and/or separation. Further investigation revealed that the technique used by the product assembler while tipping the catheter likely contributed to this nonconformance. No reports of illness or injury have been associated with this issue to date. Potential adverse events that may occur as a result of catheter tip fracture and/or separation include loss of device function, the need for medical intervention to retrieve a separated segment, and complications resulting from a separated tip occluding blood flow to end organs. Examples of such complications include stroke, kidney injury, or damage to the intestines or limbs," Cook wrote in its release.
The recalled catheter sets and trays are for femoral artery pressure monitoring, radial artery pressure monitoring, according to the release. It contains specific information about the versions and lot numbers of the individual devices that should be discontinued, quarantined and returned to Cook Medical for possible credit.
The devices were distributed between April and October 2015 in the U.S., Australia, Chile, Finland, India, Panama, Spain and other countries around the world.
Tip separation was also responsible for the company's August Class I recall of 95,167 Beacon Tip Angiographic Catheters, which it later expanded in October. It was also cited in the 2013 Class I recall of Cook's Zilver PTX Drug-Eluting Peripheral Stent. One death occurred when the tip of the device's delivery catheter separated itself from the instrument, according to the FDA's recall database.
The FDA has not yet classified the severity of the latest recall, but it is likely to be put in Class I, reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
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