FDA Issues Early Alert on Erbe Flexible Cryoprobes

FDA has issued an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that some devices may rupture during use. FDA says Erbe USA has advised customers to remove specific Flexible Cryoprobes from use or sale.

The devices are used to destroy tissue through extreme cold during interventional procedures. Typical applications include removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors, and conducting tissue biopsies, the alert says.

Erbe has reported that some cryoprobes can rupture or burst during activation due to insufficient adhesive applied during production. The rupture may generate a loud noise, posing a risk of tinnitus, temporary hearing loss, or persistent hearing damage for patients and healthcare personnel, the alert says. Additionally, ruptured devices can cause burns or other injuries.

As of 2/24, five serious injuries have been reported in connection with the issue.