Medtronic Neuromodulation recalls Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Read the official notice →- Date
- 2026-06-03
- Country
- United States
- Brand
- Medtronic Neuromodulation
- Product
- Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and The countries of Austria, France,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-05-20
USMedtronic Neuromodulation recalls Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG…
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare…
- 2026-01-21
- US
Medtronic Neuromodulation recalls A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and…
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
- 2025-12-31
- US
Medtronic Neuromodulation recalls Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN…
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Argentina, Aruba,…Official notice → - 2025-05-07
- US
Medtronic Neuromodulation recalls Enhanced Verify Evaluation Handset (CFN HH90130FA)
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered…
FDA · DeviceMedtronic NeuromodulationUS Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL,…Official notice → - 2025-04-16
- US
Medtronic Neuromodulation recalls Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model…
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
FDA · DeviceMedtronic NeuromodulationWorldwide Distribution: US (Nationwide) and OUS (Global) to countries of:…Official notice → - 2025-04-09
- US
Medtronic Neuromodulation recalls A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →
Other drugs & medical recalls in the United States
- 2026-06-03
- US
Medline Industries, LP recalls Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer…
FDA · DeviceMedline Industries, LPUS Nationwide distribution in the states of California.Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),…
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada,…Official notice → - US
GE Medical Systems Information Technologies Inc recalls GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA;…
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF…
- US
Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
FDA · DeviceDevicor Medical Products IncWorldwide distribution - US Nationwide and the countries of Canada, Singapore.Official notice → - US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper…
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Denmark,…Official notice → - US
Medline Industries, LP recalls Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2)…
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and…
FDA · DeviceMedline Industries, LPWorldwide - US Nationwide distribution in the US Territory of Virgin Islands…Official notice →