Recall Z-0371-2025

Reason for recall

The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.

FDA-determined cause: Employee error

Action taken

On 10/16/2024, the firm sent an "URGENT: Medical Device Product Removal" letter via FedEx or email to customers informing them that the Venclose RF Ablation Catheters may have been manufactured with internal wiring errors that could cause inaccurate temperature detection resulting in devices reaching temperatures higher than intended, while the user receives incorrect warnings that the catheter has not reached temperature. Customers are instructed to: 1. Please cease use of product listed in this letter, and immediately quarantine all affected product remaining in their possession. 2. The Venclose" RF Generator, which is used in conjunction with the Venclose" RF Ablation Catheters, contains software that requires an upgrade to be performed prior to using the impacted Venclose" RF Ablation Catheters. Venclose" RF Ablation Catheters that are not listed as impacted as per attachment 1, can continue to be used. 3. The affected devices should not be used until after the Venclose" RF Generator software has been updated by a BD representative. 4. A BD Representative will contact your facility in order to arrange the upgrade to your facility s Venclose" RF Generator software. The upgrade will be performed by a BD Representative upon completion of the Customer Response Form. 5. After the confirmed Venclose" RF Generator software has been updated, the products listed in this letter can be used as normal. 6. Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, please ensure that these entities are contacted and informed of the recall. 7. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not you have any of the impacted product so that BD may acknowledge your receipt of this notification. Indicate on the response form that the impacted product has been was quarantined by