FDA Early Alert: Erbe USA Cryoprobes Rupture Risk

Detected March 11th, 2026

Summary

The FDA issued an Early Alert regarding Erbe USA Flexible Cryoprobes due to a risk of rupture during activation, potentially causing injuries and hearing loss. Erbe USA has recalled affected lots and recommended discontinuing use.

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What changed

The FDA has issued an Early Alert concerning Erbe USA Flexible Cryoprobes (specific part numbers listed) that have been reported to rupture during activation due to insufficient adhesive application. This defect can cause a loud noise, leading to potential hearing damage (tinnitus, temporary or persistent hearing loss), as well as physical injuries and burns. As of February 24, five serious injuries have been reported, with no deaths.

Healthcare providers and facilities using these cryoprobes are instructed to immediately discontinue use, identify, remove, and quarantine affected devices. Erbe USA has notified customers and requested they examine inventory, quarantine devices, and ensure all relevant personnel and downstream distributors are informed of the notification. This alert signifies a potentially high-risk device issue, and the FDA will provide updates as more information becomes available.

What to do next

Discontinue use of affected Erbe USA Flexible Cryoprobes.
Identify, remove, and quarantine all affected devices from inventory.
Ensure all relevant personnel and downstream distributors are notified of the issue.

Source document (simplified)

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 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.