FDA Device Recalls

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).

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.

Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile

Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile

i-STAT EG7+ cartridge. List Number: 03P76-25.

Model Number L211 PROPONENT DR SL MRI Pacemaker

Model Number S702, ALTRUA 2 DR SL Pacemaker

Model Number U128, VALITUDE CRT-P EL MRI

Model Number L231, PROPONENT DR EL MRI Pacemaker

Model Number L101, ESSENTIO DR SL Pacemaker

Model Number L209 PROPONENT DR (VDD) SL Pacemaker

Model Number U226, VISIONIST CRT-P EL

PROPONENT SR SL (Model L200)

Model Number U228, VISIONIST CRT-P EL MRI

Model Number L221 PROPONENT DR EL Pacemaker

Model Number L131, ESSENTIO DR EL MRI Pacemaker

ACCOLADE DR EL MRI (Model L331)

MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

Model Number L121 ESSENTIO DR EL Pacemaker