Erbe USA has issued an FDA MedWatch early alert over a potential rupture of flexible Cryoprobes during activation, posing risks of hearing loss, tinnitus, burns, or other injuries.
Source: FDA MedWatch
What happened
The FDA says this recall is the most serious category. Erbe USA updated its customers with a notification to remove one part number; there are no affected lots tied to that part number, but the core safety actions remain: discontinue use and quarantine affected devices.
On February 12, Erbe USA told customers to discontinue use of devices with the affected lot numbers, examine inventory, remove and quarantine identified devices, and ensure all personnel near activation read the notification. If devices have moved, the new location and personnel should receive a copy of the notification, and distributors should be informed of any further distribution.
Erbe has reported instances where the flexible cryoprobes rupture or burst during activation. The rupture is linked to insufficient adhesive applied during production, allowing excessive input pressure. The result is a loud failure sound that can cause tinnitus or temporary or permanent hearing loss, and the device can cause injuries or burns to users or nearby people.
As of February 24, five serious injuries had been reported; there have been no deaths attributed to this issue.
What to do now for facilities
- Discontinue use of devices with the affected lot numbers.
- Inspect inventory and quarantine any units that match the affected lots.
- Ensure all personnel involved in device activation read the notification content.
- If the devices have been transferred, notify the new location and personnel and provide them with the notification.
- If further distribution occurred, identify all locations and forward this communication.
For U.S. customers with questions or adverse events, Erbe USA can be reached at 770-955-4400.
Important context for operators
These protocols reflect the FDA’s emphasis on rapid containment and traceability in a high-risk device category. The incident underscores the value of robust supplier and QA controls to prevent adhesive defects from reaching production lines and clinics.