FDA announces recall of interventional product that could cause ‘serious injury or death’
The U.S. Food and Drug Administration has announced the recall of a product used in interventional procedures amid concern it could cause patient harm.
Vendor Centerline Biomedical recently initiated the action, removing certain IOPS Guidewires, used in vascular procedures, from where they are utilized or sold. The coating on the guidewires (for lot 2404-2005) has the potential to delaminate when inserted, authorities reported on Friday.
“When this issue occurs, there is the possibility that part of the guidewire coating could be left inside of the patient, leading to a retained medical device,” according to an FDA update posted June 13, adding that this can lead to “extended procedure time and/or additional medical procedures to remove the retained medical device.”
This is a Class 1 recall, the FDA’s most serious designation, meaning misuse “may cause serious injury or death.” However, the agency emphasized there have been zero reports of patient harm.
Cleveland-based Centerline Biomedical sent a letter to all impacted customers on April 11, detailing recommended actions. It’s urging providers to review their inventory to determine if they have any impacted lots and pass them along to an account manager to be replaced at zero cost. Healthcare professionals also can report any adverse reactions or quality problems to MedWatch, the FDA said.
Centerline first earned FDA clearance for the positioning system in 2019, with an updated version also approved in March. The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy captured via 3D modeling from CT scans. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires for endovascular interventions in the descending aorta. The product is typically used as an adjunct to fluoroscopic imaging, according to the original 2019 application documents.
Companies such as GE HealthCare and Siemens have previously recalled products in the same regulatory category as the system, MedTech Dive noted Friday. However, most were Class 2 recalls, indicating a risk of temporary or medically reversible harm.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.