A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Neuromodulation or your healthcare provider for instructions. Notification method: Letter
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Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor. Reason: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.. Classification: Class II. Quantity: 275 units. Distribution: Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
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A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
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 cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
Medtronic Neuromodulation recalled 7,123 units of the Vanta Clinician Programmer Application on December 3, 2025. The software may not function as intended, potentially delaying surgical procedures. Healthcare providers and patients must stop using the software immediately.
Medtronic Neuromodulation recalled 7,667 Clinician Programmer Applications on November 20, 2025. A software issue may prevent patients from resuming therapy, leading to a recurrence of pain symptoms. Affected models include A71100 and associated tablets.