Drugs & medicalClass II

Medtronic Vascular, Inc. recalls Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only

Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

Read the official notice →
Date
2022-05-18
Country
United States
Brand
Medtronic Vascular
Product
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Classification
Class II
Units
Worldwide distribution - US Nationwide distribution in the states of Alabama,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Vascular recalls

  1. 2022-03-02
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    Medtronic Vascular, Inc. recalls Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE;…

    Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a…

    FDA · DeviceMedtronic Vascular, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL,…Official notice →
  3. 2021-12-01
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    Medtronic Vascular, Inc. recalls Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT…

    Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

    FDA · DeviceMedtronic Vascular, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL,…Official notice →
  5. US
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    Medtronic Vascular, Inc. recalls Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

    During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube

    FDA · DeviceMedtronic Vascular, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL,…Official notice →
All 4 Medtronic Vascular recalls →

Other drugs & medical recalls in the United States

  1. 2022-05-18
  2. US
    Drugs & medicalClass II

    USA Medical, LLC recalls Diagnostic Kit SARS-cCo V Antigen Rapid Test

    COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.

    FDA · DeviceUSA Medical, LLCU.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and…Official notice →
  3. US
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    Olympus Corporation of the Americas recalls BF-3C160: EVIS EXERA Bronchovideoscope

    Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using…

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass I

    Woodside Acquisitions Inc. recalls Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

    FDA · DeviceWoodside Acquisitions Inc.US distributions to states of: AL and GA.Official notice →
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    Philips North America Llc recalls Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of…

    When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure…

    FDA · DevicePhilips North America LlcDevices were distributed to the following US states: FL, ID, NJ, OK, SC and…Official notice →
  6. US
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    American Contract Systems, Inc. recalls ACS Cath Lab Pack

    Product was sterilized with a higher than specification EO concentration.

    FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of IL, MO, NE, and TX.Official notice →
  7. US
    Drugs & medicalClass I

    MESA BIOTECH, INC recalls Accula SARS-CoV-2 Test, REF: COV4100

    SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.

    FDA · DeviceMESA BIOTECH, INCUS Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA,…Official notice →
See all drugs & medical recalls →