The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1571-2013·Announced 2013-07-03

Medtronic SynchroMed EL Pumps Recalled for Unintended Drug Delivery

Medtronic is recalling SynchroMed EL implantable pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose.

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 is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion…"

Plain-English summary

Medtronic Neuromodulation is recalling the SynchroMed EL Programmable pumps, including models 8626, 8626L, 8627, and 8627L. These implantable infusion pumps are used to deliver prescribed drugs to specific sites in the body for conditions such as chronic pain, spasticity, and cancer. The recall covers an estimated 261,109 devices implanted worldwide, with distribution across the United States and internationally.

The recall is issued because of a risk of unintended drug delivery during the priming bolus function. This malfunction can contribute to patient overdose or underdose symptoms, which may be clinically relevant. Medtronic is providing healthcare professionals with safety information and patient management recommendations to address this issue.

Patients with these implanted pumps should consult their healthcare providers for guidance on managing the device and monitoring for any adverse symptoms related to drug delivery.

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. Product Usage: The pump is part of an infusion system that stores and delivers a…
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Implantable Infusion 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

Distributed nationwide across the United States.

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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