Medtronic Synchromed II Pumps Recalled for Potential Motor Stall
Medtronic is recalling Synchromed II programmable pumps due to a potential foreign particle that could cause a permanent motor stall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves an implanted medical device with a defect that could lead to a permanent motor stall, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Medtronic Neuromodulation is recalling 10,820 units of the Synchromed II programmable pump, specifically Model numbers 8637-20 and 8637-40. The recall is being conducted under FDA recall number Z-0508-2020.
The recall is due to a potential for the presence of a foreign particle inside the pump motor assembly. This particle could interfere with the motor gear rotation, leading to a permanent motor stall. The affected units were distributed in the US, Canada, Asia-Pacific, China, Europe, the Middle East, Africa, and Latin America.
Patients with these implanted devices should contact their healthcare provider for evaluation and management of the device. The specific serial numbers affected are listed in the official FDA recall record.
The recalled product
- Product
- Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 10,820
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighFemoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
Same hazard · motor stall
See all →- HighMedtronic Recalls Unimplanted SynchroMed II Pumps Due to Motor Stall Risk
FDA (Devices) · 2018-03-14
- SevereMedtronic SynchroMed II Pumps Recalled for Motor Stall Risk
FDA (Devices) · 2012-12-19
- HighCareFusion Recalls Alaris Pump Module 8100 Due to Motor Stalls
FDA (Devices) · 2012-08-22