Recall Z-0657-2022 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Medtronic Vascular, Inc.
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE; ENBF2813C145EE; ENBF2813C170EE; ENBF2816C120EE; ENBF2816C145EE; ENBF2816C170EE; ENBF
| Date | Dec 21, 2021 |
| Status | Open, Classified |
| Reason | Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable. |
| Root cause | Nonconforming Material/Component |
| Action | Beginning 12/22/2021, the firm verbally communicated with Outside the Unites States customer and followed with a written begin on or about 01/19/2022 via regionally approved method. Beginning on 12/23/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS 2-day delivery to U.S. customers informing them that a specific subset of stent graft systems may be susceptible to a delivery system component failure. Please note that this is a new recall and not related to any prior recalls performed on the delivery system (Event Numbers 88028, 88158 and 88951). For this recall, devices |
| Quantity | 14,629 devices |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MOMS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.