Early Alert: Flexible Cryoprobe Issue from Erbe USA
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Erbe USA has issued a letter to affected customers recommending certain Erbe Flexible Cryprobes be removed from where they are used or sold. Affected devices:
| Part Number | Part Description | Unique Device Identifier |
|---|---|---|
| 20402-401 | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) | Each: 04050147021778 Pack: 04050147021785 |
| 20402-402 | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L757mm) | Each: 04050147021792 Pack: 04050147021808 |
| 20402-410 | Flexible Cryoprobe (OD 1.7mm, L1.15mm) | Each: 04050147021815 Pack: 04050147021822 |
| 20402-411 | Flexible Cryoprobe (OD 2.4mm, L1.15mm) | Each: 04050147021839 Pack: 04050147021846 |
Full list of affected lots: Erbe Cryoprobe Affected Lots
What to Do
Discontinue use of affected products. Identify, remove, and quarantine affected devices.
On February 12, Erbe USA sent all affected customers a letter requesting their customers take the following actions:
- Discontinue use of products with the affected lot numbers.
- Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers.
- Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification.
- If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification.
- If you have further distributed this product, identify your locations, and forward this notification to them.
Check this web page 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.
Reason for Alert
Erbe USA has reported instances of the affected Cryoprobes rupturing or bursting during activation. The rupture is caused by insufficient adhesive being applied during production, leading to excessive input pressure.
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 rupture of the device may also lead to injuries and burns.
As of February 24, Erbe USA has reported five serious injuries, and no deaths associated with this issue.
Device Use
Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Erbe USA at 770-955-4400.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.