FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes
The FDA’s Center for Devices and Radiological Health (CDRH) has issued an Early Alert regarding a potentially high-risk issue involving certain flexible cryoprobes manufactured by Erbe USA.
Issue Overview
Erbe USA has identified a defect in specific cryoprobe models that may cause the device to rupture or burst during activation. The root cause of the issue is insufficient adhesive applied during manufacturing, resulting in excessive internal pressure leading to device failure
Risk to Patients and Users
A device rupture may result in a loud explosive sound, tinnitus or hearing loss (temporary or permanent) and burns or physical injury to patients or healthcare personnel.
As of February 24, five serious injuries were reported and no deaths were reported.
Required Actions (Immediate)
The FDA and manufacturer are advising all users to immediately discontinue use of affected devices, identify and quarantine impacted lot numbers, notify all relevant personnel and downstream users, and ensure redistributed products are tracked and recalled
Device Context
Flexible cryoprobes are used in interventional procedures for tissue destruction (cryotherapy), removal of foreign bodies, clots, and mucus plugs, tumor debulking, and biopsy support.
Given their use in critical airway and tissue procedures, device integrity is essential.
Regulatory Status
This is an FDA Early Alert, indicating a potentially high-risk issue under active review. Additional updates may follow as more data becomes available.
MDP Insight: What This Means for Manufacturers and Providers
This alert highlights several important regulatory and quality considerations.
Manufacturing Controls Matter
A seemingly minor issue, adhesive application, resulted in a high-risk device failure mode. This reinforces the importance of process validation, supplier/material controls, and production consistency.
Risk Management Must Address Use Conditions
Devices used under pressure or extreme conditions require robust design controls that include a failure mode analysis.
Field Action Execution Is Critical
Effective recall/notification processes must ensure rapid identification of affected lots, clear communication across distribution chains, and user awareness at the point of care.
Bottom Line
This event underscores how manufacturing variability can translate directly into patient risk, particularly in interventional devices. For manufacturers, it is a reminder that small process deviations can have large clinical consequences, and postmarket surveillance and rapid response systems are essential.
Download a list of recalled product lot numbers
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