Medtronic Neuromodulation recalls Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
inability to reprogram one device
Read the official notice →- Date
- 2024-05-08
- Country
- United States
- Brand
- Medtronic Neuromodulation
- Product
- Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
- Classification
- Class II
- Units
- International distribution in the country of UK.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-09-18
USMedtronic Neuromodulation recalls Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset…
A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
- 2024-07-31
- US
Medtronic Neuromodulation recalls A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605,…
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2024-07-24
- US
Medtronic Neuromodulation recalls Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead…
FDA · DeviceMedtronic NeuromodulationWorldwide Distribution: US (nationwide) and OUS (foreign) countries of:…Official notice → - 2024-01-31
- US
Medtronic Neuromodulation recalls Model A710 Intellis Clinician Programmer Application, version 2.0.97
Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability…
- 2024-01-03
- US
Medtronic Neuromodulation recalls Medtronic SynchroMed II, Model 8637-20, Programmable pump
Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug…
- 2023-11-29
- US
Medtronic 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 →
Other drugs & medical recalls in the United States
- 2024-05-08
- US
Abbott Medical recalls Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
FDA · DeviceAbbott MedicalUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - US
Allergan Sales, LLC recalls Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
FDA · DeviceAllergan Sales, LLCUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
Thoratec Corp. recalls Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
FDA · DeviceThoratec Corp.Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL,…Official notice → - US
Viatris Inc recalls Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC…
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
- US
- US
Regeneron Pharmaceuticals Inc recalls EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by:…
Lack of Assurance of Sterility: Complaints of syringe breakage