AABIP Advocacy Statement

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AABIP Position Statement on the Use of ERBE Cryoprobes for Bronchoscopy (download pdf) 
Issued by the American Association for Bronchology and Interventional Pulmonology (AABIP)

Background: 
The AABIP Advocacy Committee is sharing this update to promote awareness regarding recent reports of adverse events involving affected (i.e. specific lot numbers) flexible cryoprobes used in bronchoscopy. According to information provided by the manufacturer, a few cryoprobes experienced rupture of the outer tubing during routine pre-procedure testing, prior to patient use. These events were associated with a specific manufacturing time frame, and the manufacturer investigation identified a connector-related fixation issue affecting internal high-pressure tubing as the likely mechanism. The manufacturer has reported implementing manufacturing and quality-control enhancements, including improvements in adhesive stabilization and inspection processes, to reduce the likelihood of recurrence. 

Members are encouraged to:

• Follow ERBE’s instructions regarding checking the inventory and remove any identified probes with the affected lot numbers.

• Continue routine pre-procedure testing per manufacturer instructions

• Perform testing away from patients and nonessential staff

• Follow institutional reporting pathways if unexpected device behavior is observed

• Discontinue use of the products with the affected lot number as mentioned in ERBE’s notification letter 

• Report any complaints to ERBE’s Technical Service Department as mentioned in the notification letter

• Report adverse events experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program: www.fda.gov/medwatch   

• Use the MAUDE (Manufacturer and User Facility Device Experience) reporting system to learn more about submitting reports to the FDA regarding adverse events:  https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude-database (last accessed on 2/23/2026) 

The Advocacy Committee will continue to monitor this issue and is actively awaiting additional clarification and follow-up information from ERBE. ERBE has already sent a Recall Notification to healthcare professionals recalling all affected ERBE flexible cryoprobes including 1.1mm, 1.7 mm and 2.4 mm probes (pdf).  We encourage members and users of ERBE cryoprobes to carefully read the field action notification letter and act accordingly. Further communication will be provided as new guidance becomes available.

We appreciate your attention and continued commitment to patient safety.

¹

¹ Document drafted by Ashutosh Sachdeva, MD and reviewed, edited and approved by the AABIP Advocacy Committee on February 19th 2026.