Agency classClass IOur severity:Severe FDA (Devices)·Z-0497-2013·Announced 2012-12-19

Medtronic SynchroMed II Pumps Recalled for Motor Stall Risk

Medtronic is recalling SynchroMed II pumps because unapproved drugs can cause motor stalls and stop 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 agency classification is Class I, and the rubric mandates a score of at least 4 for FDA Class I recalls. Additionally, the hazard involves the cessation of drug infusion, which is a significant injury risk.

Plain-English summary

Medtronic Neuromodulation is recalling 174,700 SynchroMed II infusion pumps, Model 8637. These devices are implantable systems used to store and deliver prescribed drugs to specific sites in the body. 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. This means the pump may stop working and fail to deliver the medication as intended.

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. As part of this process, Medtronic is retrieving any unused pumps. Healthcare professionals were notified of the impact of unapproved drugs on the system's performance.

The recalled product

Product: Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 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 site. The implantable components of the…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Implantable Infusion Pump
Hazard: motor-stall
cessation-of-infusion
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.

See all 2 products in this recall →

Same manufacturer · Medtronic Neuromodulation

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