Medtronic Neuromodulation recalls Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an…
Read the official notice →- Date
- 2023-10-11
- Country
- United States
- Brand
- Medtronic Neuromodulation
- Product
- Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide (there was government and military…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2023-11-29
USMedtronic Neuromodulation recalls Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
FDA · DeviceMedtronic NeuromodulationInternational distribution to the countries of S. Korea and Turkey.Official notice →- 2023-11-08
- US
Medtronic Neuromodulation recalls LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
- 2023-10-25
- US
Medtronic Neuromodulation recalls SenSight Connector Plug, Model Number B31061.
Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.
- 2023-08-16
- US
Medtronic Neuromodulation recalls Medtronic InterStim Ground Pad REF 041826
Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
FDA · DeviceMedtronic NeuromodulationInternational distribution to the country of Iran.Official notice → - 2023-08-02
- US
Medtronic Neuromodulation recalls A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not…
FDA · DeviceMedtronic NeuromodulationInternational distribution to the countries of Israel and Serbia.Official notice → - 2023-07-05
- US
Medtronic Neuromodulation recalls Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue…
Other drugs & medical recalls in the United States
- 2023-10-11
- US
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Thoratec Corp. recalls Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while…
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GE Medical Systems China Co., Ltd. recalls F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
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FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Philips North America Llc recalls EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product…
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Apellis Pharmaceuticals, Inc. recalls Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body…
19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle…