Recall Z-1898-2021— Bard Peripheral Vascular Inc

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2020-12-14. FDA's recall record names no specific 510(k) clearance for this event. Product: VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS; VENEL10080 /Venovo 8F 10/80/1200mm OUS; VENEL10100 /Venovo 8F 10/100/1200mm OUS; VENEL10120 /Venovo 8F 10/120/1200mm OUS; VENEL10140 /Venovo 8F 10/140/1200mm OUS; VENEL10160 /Venovo 8F10/160/1200mm OUS; VENEL12040 /Venovo 8F 12/40/1200mm OUS; VENEL12060 /Venovo 8F 12/60/1200mm OUS; VENEL12080 /Venovo 8F 12/80/1200mm OUS; VENEL12100 /Venovo 8F 12/100/1200mm OUS; VENEL12120 /Venovo 8F 12/120/1200mm OUS; VENEL12140 /Venovo 8F 12/140/1200mm OUS; VENEL12160 /Venovo 8F 12/160/1200mm OUS; VENEM10040 /Venovo 8F 10/40/800mm OUS; VENEM10060 /Venovo 8F 10/60/800mm OUS; VENEM10080 /Venovo 8F 10/80/800mm OUS; VENEM10100 /Venovo 8F 10/100/800mm OUS; VENEM10120 /Venovo 8F 10/120/800mm OUS; VENEM10140 /Venovo 8F 10/140/800mm OUS; VENEM10160 /Venovo 8F 10/160/800mm OUS; VENEM12040 /Venovo 8F 12/40/800mm OUS; VENEM12060 /Venovo 8F 12/60/800mm OUS; VENEM12080 /Venovo 8F 12/80/800mm OUS; VENEM12100 /Venovo 8F 12/100/800mm OUS; VENEM12120 /Venovo 8F 12/120/800mm OUS; VENEM12140 /Venovo 8F 12/140/800mm OUS; VENEM12160 /Venovo 8F 12/160/800mm OUS; VENUL10040 /Venovo 8F 10/40/1200mm US; VENUL10060 /Venovo 8F 10/60/1200mm US; VENUL10080 /Venovo 8F 10/80/1200mm US; VENUL10100 /Venovo 8F 10/100/1200mm US; VENUL10120 /Venovo 8F 10/120/1200mm US; VENUL10140 /Venovo 8F 10/140/1200mm US; VENUL10160 /Venovo 8F 10/160/1200mm US; VENUL12040 /Venovo 8F 12/40/1200mm US; VENUL12060 /Venovo 8F 12/60/1200mm US; VENUL12080 /Venovo 8F 12/80/1200mm US; VENUL12100 /Venovo 8F 12/100/1200mm US; VENUL12120 /Venovo 8F 12/120/1200mm US; VENUL12140 /Venovo 8F 12/140/1200mm US; VENUL12160 /Venovo 8F 12/160/1200mm US; VENUM10040 /Venovo 8F 10/40/800mm US; VENUM10060 /Venovo 8F 10/60/800mm US; VENUM10080 /Venovo 8F 10/80/800mm US; VENUM10100 /Venovo 8F 10/100/800mm US; VENUM10120 /Venovo 8F 10/120/800mm US; VENUM10140 /Venovo 8F 10/140/800mm US; VENUM10160 /Venovo 8F 10/160/800mm US; VENUM12040 /Venovo 8F 12/40/800mm US; VENUM12060 /Venovo 8F 12/60/800mm US; VENUM12080 /Venovo 8F 12/80/800mm US; VENUM12100 /Venovo 8F 12/100/800mm US; VENUM12120 /Venovo 8F 12/120/800mm US; VENUM12140 /Venovo 8F 12/140/800mm US; VENUM12160 /Venovo 8F 12/160/800mm US;. Reason: Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system..

Recalling firm

Bard Peripheral Vascular Inc

Classification

Class II

Status

Ongoing

Initiated

2020-12-14

Firm location

Tempe, AZ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.