Recall Z-1898-2021

Bard Peripheral Vascular Inc · initiated December 14, 2020

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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;

Codes / lots: Product Code/GTIN: VENEL10040 /00801741102004; VENEL10060 /00801741104664; VENEL10080 /00801741104671; VENEL10100 /00801741102035; VENEL10120 /00801741102042; VENEL10140 /00801741102059; VENEL10160 /00801741102066; VENEL12040 /00801741102141; VENEL12060 /00801741102158; VENEL12080 /00801741102172; VENEL12100 /00801741102189; VENEL12120 /00801741102196; VENEL12140 /00801741102202; VENEL12160 /00801741102219; VENEM10040 /00801741101939; VENEM10060 /00801741101946; VENEM10080 /00801741101953; VENEM10100 /00801741101960; VENEM10120 /00801741101977; VENEM10140 /00801741101984; VENEM10160 /00801741101991; VENEM12040 /00801741102073; VENEM12060 /00801741102080; VENEM12080 /00801741102097; VENEM12100 /00801741102103; VENEM12120 /00801741102110; VENEM12140 /00801741102127; VENEM12160 /00801741102134; VENUL10040 /00801741103209; VENUL10060 /00801741103216; VENUL10080 /00801741103223; VENUL10100 /00801741103230; VENUL10120 /00801741103247; VENUL10140 /00801741103254; VENUL10160 /00801741103261; VENUL12040 /00801741103346; VENUL12060 /00801741103353; VENUL12080 /00801741103360; VENUL12100 /00801741103377; VENUL12120 /00801741103384; VENUL12140 /00801741103391; VENUL12160 /00801741103407…

Reason for recall

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

FDA-determined cause: Under Investigation by firm

Action taken

On 01/13/2021, the firm sent an "URGENT MEDICAL DEVICE SAFETY NOTICE" via FedEx to customers informing them that the Recalling Firm has received reports regarding the venous stent system 9F where the proximal end of the stent does not immediately expand upon deployment, and remains connected to the delivery system, and that over-manipulation or forcing the catheter delivery system in attempts to assist the stent's expansion, could potentially have a varying degree of harm associated with it. potential harm ranges from prolonging the procedure, damaging or deformity of the stent, potential vascular injury and / or hemodynamic disruption affecting the blood flow and / or a thrombotic event. The Recalling Firm is informing customers that the affected product can continue to be used, but are instructing them to: 1. Share this communication with all physicians using the Venovo" Venous Stent Systems product within their organization to ensure that they are aware of this Safety Notice. 2. Continue the use of these Venovo" Venous Stent Systems 9F, 14mm products following the Safety Notice guidance. 3. Report any adverse health consequences experienced with the use of this product to the Recalling Firm. A list of the affected Product Codes and Lot/Serial Numbers are included as Appendix 1 attached to the Recall Notification Letter. For questions/inquiries/assistance contact the Recalling Firm's Customer/Technical Support at 1-888-237-2762 (Opt 4, Opt 2) Monday thru Friday 8:00 a.m. - 5:00 p.m. CST Updated Information for Recall Expansion (dated 05/11/2021): On 05/07/2021, the firm sent additional " "URGENT MEDICAL DEVICE SAFETY NOTICE" via FedEx to customers informing them that the scope of the recall (initiated on 01/13/2021) was being expanded to include all sizes and lots within expiry date. Customer are instructed to: 1. Check all inventory locations within their institution for the affected Venous Stent System listed in Attachment A and immediately

Details

Recall number
Z-1898-2021
Initiated
December 14, 2020
Product code
QAN – Stent, Iliac Vein
Quantity
Total Devices=12,258 (U.S.= 7,234; O.U.S.=5,024)
Distribution
Worldwide distribution. US Nationwide, ALGERIA, ANDORRA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BRUNEI, BULGARIA, CHILE, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, DEUTSCHLAND, EGYPT, FINLAND, FRANCE, GEORGIA, GREECE, HONG KONG, HUNGARY, INDIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, OMAN, PANAMA, POLAND…
Recalling firm
Bard Peripheral Vascular Inc, Tempe, AZ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1897-2021 Class IIVENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F…Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected… 12/14/2020Open, Classified
Z-1899-2021 Class IIVENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F…Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected… 12/14/2020Open, Classified