Drugs & medicalClass II

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.

Read the official notice →
Date
2021-12-01
Country
United States
Brand
Medtronic Vascular
Product
Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT…
Classification
Class II
Units
Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2022-05-18
  2. US
    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.

    FDA · DeviceMedtronic Vascular, Inc.Worldwide distribution - US Nationwide distribution in the states of Alabama,…Official notice →
  3. 2022-03-02
  4. US
    Drugs & medicalClass II

    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 →
  5. 2021-12-01
  6. US
    Drugs & medicalClass II

    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. 2021-12-01
  2. US
    Drugs & medicalClass II

    Becton Dickinson Infusion Therapy Systems Inc. recalls BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min…

    There is a breach in the product packaging that renders the product non-sterile.

    FDA · DeviceBecton Dickinson Infusion Therapy Systems Inc.U.S. Nationwide Distribution: AR, AZ, MA, GA, NC, OH, WA, NY, NJ, HI, CA, MD,…Official notice →
  3. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and…

    If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide DistributionOfficial notice →
  4. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor…

    The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.

    FDA · DeviceMedtronic NeuromodulationUS Nationwide, including PR. There was government distribution but no military…Official notice →
  5. US
    Drugs & medicalClass II

    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 →
  6. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

    software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution.Official notice →
  7. US
    Drugs & medicalClass II

    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following…

    The processing of collected episode data may fail due to a software error.

    FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide distribution - US Nationwide. There was military/government…Official notice →
See all drugs & medical recalls →