Dear Health Care Professional/Provider,

The purpose of this letter is to advise you that ERBE USA is voluntarily recalling (removing) affected Erbe Flexible Cryoprobes. The probes 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.

Serious injuries have occurred or could occur due to rupturing/bursting of the cryoprobe during activation. This rupture has only been reported on the outer white tube, the part of the probe which is outside of the patient. We have a report of 5 potential serious injuries in the U.S.

Reason for Action
Through complaints, Erbe has been made aware of cases with the affected Cryoprobes rupturing/bursting during activation. The rupture causes a loud sound which could cause tinnitus, temporary hearing loss, or persistent hearing loss. In addition, if the probe is held at the rupture/burst location, minor injuries to the hand and/or fingers could occur. The rupture/burst is caused by an insufficient adhesive application in production leading to excessive input pressure. At the time of this letter, Erbe has received 43 complaints related to this product problem of the concerned lot numbers. The 43 complaints have been identified as adverse events. The concerned lot numbers consist of a total quantity of 90,034 units.

Risk to Health
The rupturing/bursting of the Cryoprobe can affect patients, healthcare professionals, or any person near the device when activated. The device failure produces a loud noise that can cause tinnitus, temporary hearing loss, or persistent hearing loss. Other potential injuries could include physical injuries from the burst, such as hand injuries and potential minor burns.

• In most reported cases, tinnitus and/or temporary hearing loss were documented.
• In one reported case, persistent hearing loss was documented.
• In four reported cases, minor injuries (i.e., hyperextended fingers, hand hurting, minor burn) were documented.

Action Required
Our records indicate that your facility has purchased an ERBECRYO^® 2 and therefore could be in possession of one or more of the affected products. Therefore, Erbe requires the following actions:

1. Discontinue use of the products with the affected lot numbers from Attachment 1.
2. Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers from Attachment 1.
3. 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.
4. Please contact Erbe at fieldaction.us@erbegroup.com or 678-483-8499, to obtain a Return Material Authorization number. Erbe will issue replacement product or credit for unused product once returned. Erbe will pay for shipping costs.
5. Please complete the Response Form and return to Erbe via the following options. Please note: response is required, even if you may not have any affected product on hand.

                a. Web portal: Device Medical Device Recall (Removal) Response Form for Erbe Cryoprobes

                b. Email Response Form as attachment to fieldaction.us@erbegroup.com.

                c. Call Erbe at 678-483-8499

       6. If a response is not received within 4 weeks of this letter, Erbe will provide a second and third reminder in 4-week increments.

       7. If you have further distributed this product, identify your locations, and forward this notification to them.

Erbe requests you to report any complaints, including any instances of ruptures/bursts, to our Technical Service Department at 770-955-4400. Adverse events experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program:

• Online: By completing and submitting the report online at: www.fda.gov/medwatch
• Regular mail or fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178

Actions Taken by Erbe
Erbe has improved and stabilized the manufacturing process and implemented additional inspection controls to ensure product specifications are met.
Erbe fully appreciates your prompt assistance in addressing this removal action. If you require additional information, please contact our field action team at fieldaction.us@erbegroup.com or 678-483-8499.

Sincerely,

John Tartal
Senior Director of Quality and Regulatory Affairs
ERBE USA, Inc.

Download: Medical Device Recall (Removal) Letter    Download: Response Form    Download: Affected Lot Numbers