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; E
Check against the official notice below — it lists the full affected range.
Medtronic is recalling certain Endurant, Endurant II, and Endurant IIs Stent Graft Systems with specific serial numbers due to a defect in the taper tip assembly. The taper tip component may detach from the delivery system during the implant procedure. If detachment occurs, a patient may require a secondary intervention—either an endovascular procedure or surgical conversion—to attempt removal of the detached taper tip. In some cases, a physician may decide to leave the taper tip in place if it cannot be easily removed.
The recall affects 14,629 devices distributed worldwide, including throughout the United States and multiple other countries. The specific affected serial numbers are identified in the recall record. The recall source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Canary Islands, Caym Quantity: 14,629 devices Lot/code info: Model Number/GTIN: ENBF2313C120EE/00763000005528 Serial Numbers: V30540648 V30540649 V30540650 ENBF2313C145EE/00763000005535 Serial Numbers: V30528369 V30528370 V30528371 V30528374 V30528375 V30528376 V30528611 V30528612 V30528613 V30528614 V30528615 V30528616 V30528617 V30528618 V30528619 V30544486 V30544487 V30544488 V30544489 V30544491 V30544492 V30544493 V30544494 V30544953 V30544954 V30544955 V30544956 V30544957 V30544958 V30544959 V30544960 V30544961 V30544962 V30579806 V30579807 V30579808 V30579809 V30579810 V30579811 V30579812 V30579813 V30579814 V30579815 V30579816 V30579817 V30579818 V30579819 V30579820 V30579821 V30579822 V30579823 V30579824 V30579825 V30581739 V30581740 V30581741 V30581742 V30581743 V30581744 V30581745 V30581746 V30581747 V30581748 V30581749 V30581750 V30581751 V30581752 V30581753 V30581754 V30581755 V30581756 V30581757 V30581758 V30583356 V30583357 V30583358 V30583359 V30583360 V30603508 V30603509 V30603510 V30603511 V30603512 V30603513 V30603514 V30603515 V30603516 V30603517 V30603518 V30603519 V30603520 V30603521 V30603522 V30603523 V30603524 V30603525 V30603526 V30606497 V30606498 V30606499 V30606500 V30606501 V30606502 V30606503 V30606504 V30606505 V30606506 V30606507 V30606508 V30606509 V30606510 V30606511 V30606512 V30606513 V30606514 V30606515 V30606516 ENBF2313C170EE/00763000005542 Serial Numbers: V30509849 V30509850 V30509851 V30509852 V30543246 V30543247 V30543248 V30543249 V30543250 V30543301 V30543302 V30543303 V30543304 V30543305 V30
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.