Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT
Check against the official notice below — it lists the full affected range.
Medtronic Vascular, Inc. is recalling 419 Endurant IIs Stent Graft System devices due to a defect where the spindle may detach from the distal end of the spindle hypotube during stent graft deployment. The recalled devices have model number ESBF2814C103EE, ESBF2814C103EJ, or ESBF2314C103E and were distributed worldwide as well as to multiple U.S. states including California, Florida, Georgia, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and West Virginia.
The affected devices were also distributed to Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, and Switzerland. The recall source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Reason for recall: Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube. Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, Quantity: 419 devices Lot/code info: Model Number/GTIN Code/Product Description: ESBF2814C103EE 00643169780446 V30609409 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609410 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609411 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609412 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609415 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609417 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609420 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609421 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609423 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616743 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616746 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616748 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E 00643169439993 V30618898 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618899 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618902 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30618963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618964 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618965 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.