Bard Peripheral Vascular recalled 1,725 Venclose digiRF Generators on August 21, 2025. The recall stems from software version 3.35 generating false positives for catheter defects. This issue can lead to improper device functionality during clinical use.
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Bard Peripheral Vascular Inc or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Venclose digiRF Generator, Model VCRFG1, with software version 3.35. It was distributed worldwide, including across the United States, since the software update.
Software version 3.35 incorrectly flags functioning Venclose EVSRF Ablation Catheters as defective under certain temperature conditions. This can prevent necessary medical procedures and poses a risk to patient safety.
There are no reported injuries or deaths related to this software issue. The false positives result in the generator displaying a 'Red X' indicator, disabling catheter functionality.
Patients and healthcare providers must stop using the device immediately. Contact Bard Peripheral Vascular Inc or your healthcare provider for further instructions.
For more details, contact Bard Peripheral Vascular Inc. Visit the recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2638-2025.
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