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Open, Classified

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;

FDA Recall Z-1898-2021 · Posted None

Recalling FirmBard Peripheral Vascular Inc
Recall StatusOpen, Classified
Product CodeQAN
Date Initiated2020-12-14
Product QuantityTotal Devices=12,258 (U.S.= 7,234; O.U.S.=5,024)

Reason for Recall

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

Firm Action

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

Root Cause

Under Investigation by firm

Distribution Pattern

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, PORTUGAL, ROMANIA, RUSSIA, SAUDIA ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES (UAE), UNITED KINGDOM, VIETNAM

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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