Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) / Z-0464-2022

Z-0464-2022 Class II Terminated

Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Mounds View, MN

Recall Details

Product Type
Devices
Report Date
January 12, 2022
Initiation Date
November 19, 2021
Termination Date
August 16, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21,653 devices

Product Description

Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

Reason for Recall

There have been reports of stent migration.

Distribution Pattern

Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kenya, Lithuania, Malaysia, Republic of Moldova, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Viet Nam,

Code Information

The IFU for all model numbers and serial numbers.

Other recalls by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

  • Z-1707-2023 Class I — ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardiov (May 10, 2023)
  • Z-1759-2023 Class I — CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardiov (May 10, 2023)
  • Z-1718-2023 Class I — ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibr (May 10, 2023)
  • Z-1797-2023 Class I — ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardiov (May 10, 2023)
  • Z-1717-2023 Class I — ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibr (May 10, 2023)
  • Z-1796-2023 Class I — ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter (May 10, 2023)
  • Z-1782-2023 Class I — CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defi (May 10, 2023)
  • Z-1815-2023 Class I — ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibr (May 10, 2023)
  • Z-1812-2023 Class I — ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardio (May 10, 2023)
  • Z-1766-2023 Class I — CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter (May 10, 2023)