Erbe Flexible Cryoprobe Recalled Due to Risk of Rupturing and Serious Injury

What Happened

Erbe Elektromedizin Gmbh has issued a recall for several lots of its Erbe Flexible Cryoprobes. The company reported that these devices may rupture or burst during activation. According to the recall notice, serious injuries have already occurred or could potentially occur due to this specific failure mode.

Which Products Are Affected

The recall affects the following models of the Erbe Flexible Cryoprobe:

• Model/Catalogue Number: 20402-401
• Model/Catalogue Number: 20402-411
• Model/Catalogue Number: 20402-410

Health Canada notes that there are more than 10 affected lot or serial numbers associated with these models. Users are advised to contact the manufacturer directly to confirm if their specific units are included in the recall.

What You Should Do

Users must immediately stop using any products identified as part of the affected lots. Healthcare providers and facilities should follow the detailed instructions provided by Erbe in the official field safety notice. For additional information or to verify lot numbers, contact the manufacturer, Erbe Elektromedizin Gmbh, located in Tuebingen, Germany.

Why This Matters

This recall is significant because the mechanical failure of a cryoprobe during a medical procedure poses a high risk of serious injury to both patients and clinical staff due to the device rupturing under pressure.

Source

Information provided by Health Canada.