Cryoprobe Recall: Erbe USA Removes Flexible Cryoprobes
Erbe USA has initiated a recall of flexible cryoprobes due to a risk of the probes rupturing during activation.
This recall affects Erbe USA, healthcare facilities utilizing their flexible cryoprobes, and clinical teams responsible for interventional procedures using cryotechnology.
The potential for device rupture presents significant patient safety risks, including hearing loss, tinnitus, physical injury, or burns. From a regulatory perspective, this suggests a critical failure in device integrity or manufacturing quality control that warrants immediate mitigation and a thorough root cause analysis to prevent future malfunctions.
Regulatory and clinical teams should immediately identify and sequester affected flexible cryoprobes, conduct a risk assessment for patients recently treated with these devices, and ensure all field safety notices are documented for future FDA inspections.
Erbe Cryoprobes may rupture during activation, leading to potential hearing loss, tinnitus, injury, or burns.
Open in openFDA / FDA.gov