The Recall Desk
HighFDA (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.

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 a risk-of-harm product (medical device) where the hazard (loss of therapy) is significant, but the source text does not explicitly report injuries or illnesses, fitting the 'High' criteria for risk-of-harm products without reported injury.

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 s
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 →

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