Drugs & medicalClass II

Medtronic, Inc. recalls Azure S DR MRI SureScan, Product number W3DR01

Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac…

Read the official notice →
Date
2025-06-18
Country
United States
Brand
Medtronic
Product
Azure S DR MRI SureScan, Product number W3DR01
Classification
Class II
Units
International distribution of the country of UK. No US distribution.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Medtronic recalls

  1. 2025-12-10
  2. US
    Drugs & medicalClass II

    Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

    There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

    FDA · DeviceMedtronic, Inc.Worldwide - US Nationwide distribution.Official notice →
  3. 2025-07-30
  4. US
    Drugs & medicalClass II

    Medtronic, Inc. recalls Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application,…

    In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's…

    FDA · DeviceMedtronic, Inc.Worldwide - US Nationwide distribution.Official notice →
  5. 2025-07-23
  6. US
    Drugs & medicalClass II

    Medtronic, Inc. recalls Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure…

    A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a…

    FDA · DeviceMedtronic, Inc.WorldwideOfficial notice →
  7. 2024-09-25
  8. US
    Drugs & medicalClass II

    Medtronic Inc. recalls 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031,…

    Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.

    FDA · DeviceMedtronic Inc.Worldwide distribution.Official notice →
  9. 2024-07-03
  10. US
    Drugs & medicalClass II

    Medtronic Inc. recalls EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator

    Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

    FDA · DeviceMedtronic Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA,…Official notice →
  11. 2024-03-27
  12. US
    Drugs & medicalClass II

    Medtronic Inc. recalls Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

    There is a potential for sterile package breach.

    FDA · DeviceMedtronic Inc.Worldwide distribution - US Nationwide and the countries of Australia, Canary…Official notice →
All 20 Medtronic recalls →

Other drugs & medical recalls in the United States

  1. 2025-06-18
  2. US
    Drugs & medicalClass II

    QUANTUM SURGICAL SAS recalls EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the…

    Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

    FDA · DeviceQUANTUM SURGICAL SASWorldwide distribution - U.S. Nationwide distribution in the states of FL,IL,…Official notice →
  3. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

    A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the…

    FDA · DeviceBeckman Coulter, Inc.Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries…Official notice →
  4. US
    Drugs & medicalClass II

    Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box)…

    Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.

    FDA · DeviceNatus Neurology DBA Excel Tech., Ltd. (XLTEK)Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS…Official notice →
  5. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog…

    Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal…

    FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, CL, DE,…Official notice →
  6. US
    Drugs & medicalClass II

    Cardinal Health 200, LLC recalls SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

    Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

    FDA · DeviceCardinal Health 200, LLCDomestic US distribution to AK, CA, FL, MA, TX. International distribution to…Official notice →
  7. US
    Drugs & medicalClass II

    American Contract Systems, Inc. recalls LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model:…

    Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality…

    FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the state of CO.Official notice →
See all drugs & medical recalls →