Home / Recalls / Medtronic Vascular, Inc. / Z-2135-2021

Z-2135-2021 Class II Ongoing

Recalled by Medtronic Vascular, Inc. — Santa Rosa, CA

Recall Details

Product Type
Devices
Report Date
August 4, 2021
Initiation Date
June 7, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18 devices

Product Description

Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

Reason for Recall

During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

Distribution Pattern

U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.

Code Information

Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882

Other recalls by Medtronic Vascular, Inc.

  • Z-1042-2022 Class II — Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, R (March 23, 2022)
  • Z-1043-2022 Class II — Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, (March 23, 2022)
  • Z-0657-2022 Class II — Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant (December 21, 2021)
  • Z-0291-2022 Class II — Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2 (October 15, 2021)
  • Z-0290-2022 Class II — Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF252 (October 15, 2021)
  • Z-0292-2022 Class II — Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF (October 15, 2021)
  • Z-2136-2021 Class II — Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft (June 7, 2021)
  • Z-1860-2021 Class I — Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, (May 4, 2021)
  • Z-1976-2021 Class II — Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For (April 28, 2021)
  • Z-1201-2021 Class I — Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions (February 12, 2021)