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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall."
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.
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