FDA issues ‘high risk’ safety alert for radiology device after 5 serious injuries
The U.S. Food and Drug Administration issued a safety alert pertaining to a key interventional radiology device Tuesday, warning the product poses “high risk” to patients.
Its warning pertains to Flexible Cryoprobes, made by Marietta, Georgia-based manufacturer Erbe USA. Such specialized instruments are typically used to deliver extreme cold, freezing tissue to remove tumors or obtain biopsies.
However, Erbe USA is warning customers of instances where its Cryoprobes may rupture or burst during activation. This is caused by insufficient adhesive being applied during production, leading to “excessive input pressure.” It first issued an “urgent medical device recall” notice to customers on Feb. 12.
“The rupture causes a loud sound which could cause tinnitus, temporary hearing loss, or persistent hearing loss to patients, healthcare professionals, or any person near the device when activated,” the FDA said in its safety alert, published March 10. “The rupture of the device may also lead to injuries and burns.”
As of Feb. 24, Erbe USA has received reports of five serious injuries but no deaths. Flexible Cryoprobes are commonly used during interventional procedures such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tumors and tissue biopsies.
Erbe USA is advising customers to discontinue use of products from the affected lot numbers. It’s also suggesting that all personnel within the vicinity of device activation carefully read this content, and check back to this webpage for updates.
“The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” the notice reads.
In its February notice, Erbe USA said it has received 43 complaints related to this product problem, all of which were identified as adverse events. Altogether, the impacted lot numbers consist of 90,034 total units. In most reported cases, tinnitus or temporary hearing loss was documented. In one other, persistent hearing loss occurred, while four others led to minor injuries such as hyperextended fingers, hand pain or minor burns.
“Erbe has improved and stabilized the manufacturing process and implemented additional inspection controls to ensure product specifications are met,” John Tartal, senior director of quality and regulatory affairs for the company, said in the notice to customers. “Erbe fully appreciates your prompt assistance in addressing this removal action.”
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.