Medtronic SynchroMed EL Pumps Recalled Due to Unapproved Drug Interactions
Medtronic is recalling SynchroMed EL implantable infusion pumps because using unapproved drugs can cause the pump to stop working, halting drug delivery.
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 recall involves an implanted medical device where a failure (motor stall) results in the cessation of drug infusion, which constitutes a significant injury risk or serious health consequence, aligning with the 'Severe' criteria for significant injury reports or high-risk device failures.
Plain-English summary
Medtronic Neuromodulation is recalling 174,700 SynchroMed EL implantable infusion pumps, including models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. These devices are part of an implanted infusion system used for the chronic infusion of drugs or fluids. The pumps were distributed worldwide, including in the United States, Canada, and Mexico.
The recall was initiated because the use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. Medtronic notified healthcare professionals regarding the impact of these unapproved drugs on the performance of the pump system.
In an update dated February 1, 2016, Medtronic received approval to incorporate enhancements to the SynchroMed II pump that decrease the potential for internal electrical shorting and motor corrosion. The company is retrieving any unused pumps.
The recalled product
- Product
- SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated…
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 174,700
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 and SynchroMed II 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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