Stryker Catheter Recall Issued Due To Tip Separation

A recall announced last week suggests that patients could face a risk of severe injury or death due to a risk that the tips of a catheter distributed by Stryker may break off. 

The Angiodynamicsw Soft Vu Omni Flush Angigraphic Catheter recall was announced by the FDA last week, after Stryker Sustainability Solutions sent a customer notification last month about the risk of problems with the catheters. Due to severe risks posed for patients, the FDA classified the action as a Class I medical device recall, suggesting that use of the device poses a risk of serious injury or death.

These particular catheters are used to inject contrast dye into blood vessels before a cardiac angiogram is performed.

According to the recall notice, there have been reports of the catheter tip separating from the main body, which can cause loss of device function, the potential need for surgical intervention to retrieve separated tips from inside the patient, as well as potential blood flow blockages. In more serious cases, catheter tip separation can lead to internal organ damage, stroke, kidney failure and intestinal failure, as well as death.

The recall affects Angiodynamics Soft Vu Omni Flush Angiographic Catheters, with Model/Item Numbers 10732203, and lot numbers 8248U, 119965U, 158623U, 175183U, 179688U, 191185U, 210813U,225911U, 225918U, 225919U, 253202U, 277726U, 302844U, 309329U, 325680U, 343908U, 352756U, 352761U, 359352U, 363987U, 366572U, 369818U, 375883U, 772102U, 773196U, 773216U, 775985U, and 7710750U. The devices were manufactured between November 7, 2004 and December 3, 2008, and distributed between January 5, 2004, and December 3, 2008.

The FDA and Stryker are advising customers to discontinue use of the affected lots, check their inventories for recalled catheters, and ship all recalled catheters back to Stryker. Customers can contact Stryker by phone at (999) 999-3433, or by email at ssspfa@stryker.com.

The FDA is also requesting that any adverse reactions or problems linked to the recalled catheters be reported to the FDA’s MedWatch adverse event reporting system.

The recall is the latest in a series of major catheter recalls issued this year. In April, Boston Scientific issued a Fetch Aspiration Catheter recall after reports that the shafts broke during procedures, posing embolism and clotting risks to patients.

In a March recall of Arrow intra-Aortic Balloon Catheter kits, it was revealed that at least one patient death could be blamed on a defect that caused the sheath body to be separated from the sheath hub.

More recently, Cook Medical issued a Beacon Tip catheter recall in May that affected more than 4.1 million catheters and catheter kits distributed worldwide, also for tip separation problems. While no fatalities were reported in connection to that recall, there were several reports of the need for emergency removal procedures.