Drugs & medicalClass II

Medtronic Inc. recalls Medtronic SynchroMed, Model A10

The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus,…

Read the official notice →
Date
2023-12-20
Country
United States
Brand
Medtronic
Product
Medtronic SynchroMed, Model A10
Classification
Class II
Units
Foreign 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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2024-03-27
  2. 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 →
  3. 2024-01-31
  4. US
    Drugs & medicalClass II

    Medtronic Inc. recalls Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1

    During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the…

    FDA · DeviceMedtronic Inc.US Nationwide distribution in the state of Florida.Official notice →
  5. 2024-01-10
  6. US
    Drugs & medicalClass II

    Medtronic Inc. recalls Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.

    Seal defects could compromise the ability of the product packaging to maintain sterility.

    FDA · DeviceMedtronic Inc.US Nationwide distribution in the state of MN.Official notice →
  7. 2023-12-06
  8. US
    Drugs & medicalClass II

    Medtronic Inc. recalls ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor

    It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to…

    FDA · DeviceMedtronic Inc.US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic,…Official notice →
  9. 2023-11-29
  10. US
    Drugs & medicalClass II

    Medtronic Inc recalls Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6

    The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external…

    FDA · DeviceMedtronic IncWorldwide distribution - US Nationwide and the countries of Algeria, Armenia,…Official notice →
  11. 2022-09-07
  12. US
    Drugs & medicalClass II

    Medtronic Inc. recalls EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System

    Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.

    FDA · DeviceMedtronic Inc.worldwideOfficial notice →
All 20 Medtronic recalls →

Other drugs & medical recalls in the United States

  1. 2023-12-20
  2. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - Northfield recalls STERILE PVP SOLUTION, REF DYNDA1907

    The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

    FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.Official notice →
  3. US
    Drugs & medicalClass II

    Limacorporate S.p.A recalls PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

    Due to incorrect product labeling

    FDA · DeviceLimacorporate S.p.AU.S Distribution: AZ, CA, IL, LA, and NYOfficial notice →
  4. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

    Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL…Official notice →
  5. US
    Drugs & medicalClass II

    Meridian Bioscience Inc recalls Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens…

    Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.

    FDA · DeviceMeridian Bioscience IncNationwide Foreign: ItalyOfficial notice →
  6. US
    Drugs & medicalClass II

    Meridian Bioscience Inc recalls Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal…

    Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.

    FDA · DeviceMeridian Bioscience IncNationwide Foreign: ItalyOfficial notice →
  7. US
    Drugs & medicalClass II

    Riverpoint Medical, LLC recalls Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF…

    Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of…

    FDA · DeviceRiverpoint Medical, LLCU.S. Nationwide distribution in the state of CA.Official notice →
See all drugs & medical recalls →