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Medtronic Neuromodulation

Medtronic Neuromodulation Recalls

All product recalls associated with Medtronic Neuromodulation.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 61–80 of 83 recalls

Medtronic Neuromodulation: Medtronic iCon Patient Programmer, model 3037. The Patie...

Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. Without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.

FDAMay 12, 2008GA, MO, NC +1 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic Patient programmer, model 37742. The Patient p...

FDAMay 12, 2008GA, MO, NC +1 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic Synchromed II Programmable Pump , Medtronic Inc...

SynchroMed II pumps (non-implanted) may have been manufactured without propellant.

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FDAMay 1, 2008AL, AK, AZ +46 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Suction Jar Lid for Medela Vario 18 Vacuum Pump used with...

The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.

FDAApr 25, 2008AR, CA, CT +12 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Model 8709SC Indura 1P One-Piece Intrathecal Catheter Me...

The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.

FDAApr 14, 2008Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Model 8731SC Intrathecal Catheter Medtronic Inc., Minneap...

FDAApr 14, 2008Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic 8578 Sutureless Pump Connector Revision Kit Med...

FDAApr 14, 2008Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Model 8596SC Intrathecal Catheter Pump Segment Revision K...

FDAApr 14, 2008Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal...

Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.

FDAMar 1, 2008FL, NC• Medtronic Neuromodulation

Medtronic Neuromodulation: IsoMed Refill Kit, Model 8553, Lot Number 60538731, is in...

Medtronic is retrieving all unused packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was released using incorrect endotoxin specification limits. Endotoxin contamination can potentially lead to fever, malaise, respiratory distress, septic shock, and death.

FDAFeb 4, 2008AL, AK, AZ +34 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic - SynchroMed EL Implantable Infusion Pump, Mode...

Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these d

FDAJan 16, 2008WA, PR• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic SynchroMed II Programmable Pump, model 8637-20....

FDAJan 16, 2008WA, PR• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic IsoMed Implantable Constant-Flow Infusion Pump,...

FDAJan 16, 2008WA, PR• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic Intrathecal Catheter Pump Segment Revision Kit;...

Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.

FDAJan 9, 2008Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic Bravo pH Capsule with Delivery System, Stomach ...

Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.

FDADec 3, 2007AL, AK, AZ +48 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic Soletra 7426, Quadripolar Multi-Programmable Ne...

Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.

FDAOct 1, 2007AL, AK, AZ +46 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic Kinetra 7428, Dual Program Neurostimulator for ...

Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.

FDAOct 1, 2007AL, AK, AZ +46 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic SynchroMed EL Programmable Pump, Model 8626-10....

Pump motor stall due to gear shaft wear

FDAAug 3, 2007AL, AK, AZ +49 more• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic InterStim II INS Model 3058 with N'Vision Inter...

A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .

FDAJun 25, 2007Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic InterStim INS (Model 3023) with N'Vision Inter ...

Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

FDAJun 25, 2007Nationwide• Medtronic Neuromodulation