Agency classClass IOur severity:Severe FDA (Devices)·Z-1579-2013·Announced 2013-07-03

Medtronic SynchroMed II Pumps Recalled for Electrical Shorting Risk

Medtronic is recalling SynchroMed II pumps due to potential electrical shorting that may cause therapy loss or reduction.

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: "Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short…"

Plain-English summary

Medtronic Neuromodulation is providing healthcare providers with safety information and patient management recommendations regarding the Medtronic SynchroMed II infusion pumps. The recall addresses a potential for electrical shorting internal to the pump.

An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm. This issue can lead to a loss of or reduction in therapy, which may result in the return of underlying symptoms. The source text does not specify the number of affected units, specific lot numbers, or reported injuries.

Healthcare providers are advised to follow the safety information and patient management recommendations provided by Medtronic Neuromodulation. Patients with implanted SynchroMed II pumps should consult their healthcare providers for guidance on managing this potential risk.

The recalled product

Product: Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Implantable Infusion Pump
Hazard: electrical-short
therapy-loss
Affected units: 261,109

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

all SynchroMed II pumps

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Medtronic Neuromodulation

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