Recall Z-1899-2021 ยท QAN Stent, Iliac Vein
Bard Peripheral Vascular Inc
VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS; VENEL14140 /Venovo 9F 14/140/1200mm OUS; VENEL14160 /Venovo 9F 14/160/1200mm OUS; VENEM14040 /Venovo 9F 14/40/800mm OUS; VENEM14060
| Date | Dec 14, 2020 |
| Status | Open, Classified |
| Reason | Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. |
| Root cause | Under Investigation by 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 vas |
| Quantity | Total Devices=23,029 (U.S.=16,582; O.U.S. =6,447) |
| 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, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.