The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1580-2013·Announced 2013-07-03

Medtronic SynchroMed EL Pumps Recalled for Electrical Shorting Risk

Medtronic is recalling SynchroMed EL pumps due to potential internal electrical shorting that may cause therapy loss.

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 EL Programmable pumps. The recall involves Models 8626, 8626L, 8627, and 8627L, which are supplied in 10 ml or 18 ml reservoir sizes. These devices are part of an infusion system that stores and delivers prescribed drugs to specific sites.

The recall is issued due to the potential for electrical shorting internal to the SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm. This malfunction can lead to a loss of or reduction in therapy, which may result in the return of underlying symptoms.

An estimated 261,109 devices are implanted worldwide. Healthcare providers are advised to review the safety information and follow patient management recommendations to address the potential impact on patient therapy.

The recalled product

Product
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 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…
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Implantable Pump
Hazard
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 EL 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 →

Related recalls

Same manufacturer · Medtronic Neuromodulation

See all →

Same hazard · electrical short

See all →

Similar recalls