Health & Personal Care
HIGH
FDA DEVICE
Bard Peripheral Vascular Venclose DigiRF Generator Recall Affects 1,725 Units Worldwide
Bard Peripheral Vascular
Software version
294 recalls tagged with “battery powered”.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Potential for activation of an abnormal alarm pause.