The Recall Desk
SevereFDA (Devices)·Z-1570-2014·Announced 2014-05-14

Medtronic SynchroMed II Implantable Pumps Recalled for Overinfusion Risk

Medtronic is recalling SynchroMed II implantable drug infusion pumps because they may overinfuse medication, potentially causing life-threatening overdose or drug withdrawal.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source explicitly states that overinfusion can result in a 'life-threatening overdose,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or severe risk of harm, warranting a score of 4.

Plain-English summary

Medtronic Neuromodulation is recalling the SynchroMed II Implantable Drug Infusion Pump, Models 8637-20 and 8637-40. This recall involves 195,198 pumps distributed worldwide, including 146,435 in the United States and 48,763 outside the US.

The recall is issued to provide new information regarding overinfusion associated with these devices. Overinfusion can result in a life-threatening overdose of the prescribed drug. Additionally, the issue can lead to drug withdrawal due to the premature emptying of the pump.

The source notes a low reported rate of occurrence for this issue and states that it is currently impossible to predict which specific pumps may be at risk. Consequently, Medtronic is not recommending a specific corrective action such as replacement or removal in the provided text, but rather issuing this notification to inform users of the potential hazard.

The recalled product

Product
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Implantable Drug Infusion Pump
Hazard

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)

  • This Medical Device Correction notification affects all SynchroMed II pumps.

Distribution

Distribution scope not specified by the agency.

Related recalls

Same manufacturer · Medtronic Neuromodulation

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