adequate brachial or axillary access that is compatible with vascular access techniques, devices, or accessories.proximal neck length of ≥10 mm or ≥4 mm and 15 mm with a balloon expandable covered stent deployed in a parallel graft technique in one or two renal arteries and with insignificant calcification, or insignificant thrombus with ≤60° infrarenal, ≤45° suprarenal, and ≤45° suprasuperior mesenteric artery angulation (supraSMA angulation) and an aortic diameter approximately 20% to 30% smaller than the labelled Endurant II/Endurant IIs stent graft diameter.aortic neck diameters with a range of 19 to 32 mm.In addition, for treatment of infrarenal abdominal aortic or aortoiliac aneurysms, the following patient characteristics apply: aneurysm that is at least 1.5 times the diameter of the normal infrarenal aorta. aneurysm diameter of 4 to 5 cm, which has also increased in size by 0.5 cm in the last 6 months.morphology suitable for aneurysm repair.iliac diameters with a range of 8 to 25 mm.adequate iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories.The Endurant II/IIs stent graft system is indicated for the endovascular treatment of infrarenal or juxtarenal abdominal aortic or aortoiliac aneurysms in patients with the following characteristics: For further information, contact your local Medtronic representative and/or consult the Medtronic Europe website. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. Refer to the complete Instructions for Use manual of the Endurant II/IIs stent graft system for the indications approved in your geography. Please check your local regulatory approval status. (subsidiary of Teleflex Inc.All indications related to Endurant II/IIs Stent Graft System are not approved globally. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = FOZ and Original Applicant = Arrow International, Inc. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-85, Attn: Customer Service or email to This will allow us to document your receipt of this letter.Īdverse reactions or quality problems experienced with the usġ A record in this database is created when a firm initiates a correction or removal action. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical.ģ. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-85, Attn: Customer Service or email to This will allow us to document the amount of product you have on hand for return. Immediately discontinue use and quarantine any products with the product codes and lot numbers listed above.Ģ. Inspect your inventory for the affected product codes above. We are now notifying our customers to take the following actions:ġ. Our records indicate you have received products that are subject to this action. No complaints, patient injuries or deaths have been reported at this time. If the devices sterility is compromised and the product is used it could lead to infectious complications. The product was processed through the incorrect sterilization cycle thus, the sterility of the device cannot be guaranteed. Lot Numbers: 13F19E0247, 13F19F0006, 13F19G0433Īrrow International is recalling the above product code and lots due to a potential sterility issue. On Decemthe firm distributed Urgent Medical Device Recall Communication letters by mail stating:Īrrow Endurance" Extended Dwell Peripheral Catheter SystemĪrrow International is voluntarily recalling the following product code and lots: Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH. Class 2 Device Recall Arrow Endurance Catheter SystemĬatheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZĪrrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
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