Bard Peripheral Vascular Inc: Device Recall

Recall Details

Recall Number

Z-2638-2025

Classification

Class II

Product Type

Device

Recalling Firm

Bard Peripheral Vascular Inc

Status

Ongoing

Date Initiated

08/21/2025

Location

Tempe, AZ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,725

Reason for Recall

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.

Product Description

Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of NJ, NY, FL, LA, VA, CA, TX, NV, PA, NE, TN, IL, AZ, SC, AK, GA, CO, HI, OH, NC, WI, WV, MD, MO, AL, OK, MS, PR, KS, UT, CT, IA, MI, IN, MA, KY, WA, MT, MN, SD, ME, DE, NM, AR and the country of Malaysia.

Other Recalls by Bard Peripheral Vascular Inc

• Class II: Risk 11/06/2025
  Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
• Class I: Dangerous 02/05/2025
  Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
• Class II: Risk 09/30/2024
  Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.
• Class II: Risk 09/04/2024
  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.
• Class II: Risk 08/02/2024
  Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.

View all recalls by Bard Peripheral Vascular Inc →