Stryker Reprocessing Facility Hit with Class I Recall

Stryker Sustainability Solutions is recalling angiographic catheters that could break off inside patients, causing injury or death.

Nancy Crotti

A Stryker medical device reprocessing facility is recalling unused catheters with either incorrect or nonexistent expiration dates because their tips might break inside a patient, causing injury or death.

Customers were notified June 1, 2016, to return the resterilized Angiodynamics Soft VU Omni Flush catheters to Stryker Sustainability Solutions, Tempe, AZ, formerly Ascent Healthcare Solutions.

Tip separation leads to loss of device function, possible surgical intervention to retrieve a separated segment, or other complications such as blocking blood flow to bodily organs, according to the FDA announcement.

The catheters were manufactured between 2003 and 2008. Kalamazoo, MI-based Stryker bought Ascent(Phoenix) in 2009. Angiodynamics (Latham, NY) manufactures Soft Vu Angiographic Catheters, according to its website. They are used to inject contrast dye into blood vessels in preparation for a cardiac angiogram, a type of x-ray used to diagnose heart conditions. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. 

The catheters were part of Stryker's re-sterilization service for open-but-unused devices, according to a Stryker spokesperson. None have been re-sterilized since 2008, and Stryker no longer offers the service, the company said.

"Single use devices (SUDs) remanufactured and reprocessed by Stryker are not impacted by the recall and all activity has been completed by Sustainability Solutions in relation to this recall," the spokesperson added in an email.

Angiodynamics did not immediately respond to a request for comment.

FDA, which considers it a Class I recall, made the announcement July 21. The tips of two of the reused catheters broke off prior to being used on patients, Stryker told FDA. No one was injured. A total of 167 devices bearing model number 10732203are in circulation in the U.S. and Canada, the agency said. The recall notice lists affected lots.

Corporate sustainability research and advisory firm Green Research lauded Stryker and Becton Dickinsonin a 2012 report for  their commitment to creating businesses that "reclaim, reprocess, recycle, or remanufacture used medical products, helping hospitals reduce their own waste burden and creating new revenue stream in the process."

Healthcare facilities across the country reprocess thousands of reusable surgical instruments and devices every day--a practice that has been approved by the FDA. Most of the recent focus on reprocessed devices has been on duodenoscopes that were manufactured by Olympus,proved difficult to clean, and were linked to hundreds of superbug illnesses in the U.S. and Europe.

When performed correctly, the process of repurposing these tools removes residue and potentially infectious materials to sterilize the instruments for safe use on another patient. FDA issued final guidance on reprocessing of reusable medical devices in March 2015, focusing on cleaning and sterilization of devices.

Despite recent efforts to raise the bar on the guidelines of reusable medical devices, the consequences of reprocessing failures are still considered a threat to the medical industry.

Nancy Crotti is a contributor to Qmed.

Correction: An earlier version of this story incorrectly stated that the recalled catheters were used; in fact, they were unused. This article has also been updated with comment from Stryker.

[image courtesy of STOCKIMAGES/FREEDIGITALPHOTOS.NET]