Erbe USA recalled 33,390 Flexible Cryoprobes with oversheath used in surgery. The devices were distributed nationwide, including Puerto Rico. Probes may rupture during activation. Clinicians should stop using the device immediately and follow recall instructions.
Probes may rupture/burst during activation
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Erbe USA Inc or your healthcare provider for instructions. Notification method: E-Mail
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The Flexible Cryoprobe is a surgical instrument used for cryoablation procedures with an oversheath. It is designed to deliver extreme cold to targeted tissue under medical supervision.
A rupture or burst during activation can cause unintended tissue injury and potential procedural complications.
This recall is not described as part of a broader industry pattern.
Hospitals may face procedure delays and patients may experience safety concerns if a device ruptures during use.
Recall notice and enforcement page provide the official identifiers and lists.
Refunds or replacements are typically processed within 4-8 weeks of submission.
Keep the recall notice, device identifiers, lot numbers, receipts, and all correspondence for records.
UDI: 04050147021785 Lots: WO461310 WO461311 WO461312 WO461314 WO461315 WO461829 WO461831 WO461832 WO461833 WO461834 WO461835 WO461842 WO461843 WO461844 WO461847 WO461848 WO462117 WO462118 WO462119 WO462120 WO462121 WO462122 WO462123 WO462124 WO462125 WO462128 WO462129 WO462130 WO462373 WO462374 WO462375 WO462376 WO462377 WO462378 WO462379 WO462380 WO462387 WO462388 WO462389 WO462397 WO462825 WO462826 WO462827 WO462828 WO462829 WO462830 WO462831 WO462838 WO462839 WO462840 WO462841 WO462842 WO462843 WO462844 WO462845 WO462846 WO462847 WO462848 WO462849 WO463308 WO463309 WO463310 WO463311 WO4633
No injuries or incidents have been reported.
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