Drugs & medicalClass II

Medtronic Neuromodulation recalls Model B35200 - Percept PC BrainSense Implantable Neurostimulator

During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal…

Read the official notice →
Date
2022-01-05
Country
United States
Brand
Medtronic Neuromodulation
Product
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Classification
Class II
Units
Worldwide distribution - US Nationwide and Puerto Rico. The countries of…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Neuromodulation recalls

  1. 2022-08-31
  2. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators…

    Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable…

    FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution including in the states of…Official notice →
  3. 2022-06-01
  4. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200

    The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

    FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →
  5. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI…

    The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.

    FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →
  6. 2022-05-04
  7. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1)…

    There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.

    FDA · DeviceMedtronic NeuromodulationUS Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY,…Official notice →
  8. 2021-12-01
  9. 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 →
  10. 2021-11-10
  11. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls Clinician Programmer Application (CPA) model A610 Clinician Software Application

    A software anomaly may occur with the clinician programmer application.

    FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution and the countries of…Official notice →
All 35 Medtronic Neuromodulation recalls →

Other drugs & medical recalls in the United States

  1. 2022-01-05
  2. US
    Drugs & medicalClass II

    Migo Trading LLC recalls FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test

    Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the…

    FDA · DeviceMigo Trading LLCNYOfficial notice →
  3. US
    Drugs & medicalClass II

    Abbott recalls Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

    As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the…

    FDA · DeviceAbbottWorldwide distribution - US Nationwide distribution in the state of Missouri…Official notice →
  4. US
    Drugs & medicalClass II

    Intuitive Surgical, Inc. recalls da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605…

    Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may…

    FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of Arizona, California, Connecticut,…Official notice →
  5. US
    Drugs & medicalClass I

    Valisa MFG LLC recalls kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735,…

    Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

    FDA · DrugValisa MFG LLCNationwide in the USAOfficial notice →
  6. US
  7. US
    Drugs & medicalClass I

    Gilead Sciences, Inc. recalls Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA…

    Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.

    FDA · DrugGilead Sciences, Inc.Nationwide in the USAOfficial notice →
See all drugs & medical recalls →