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.
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 (overdose or underdose) from a medical device where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
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 prescri
- Manufacturer
- Medtronic Neuromodulation
- 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.
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