Agency classClass IOur severity:Critical FDA (Devices)·Z-1570-2013·Announced 2013-07-03

Medtronic SynchroMed II Pump Recall for Unintended Drug Delivery

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

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

Medtronic Neuromodulation is recalling the SynchroMed II implantable infusion pump, Model 8637. This device is part of an infusion system used to deliver prescribed drugs to specific sites in the body, including treatments for chronic pain, spasticity, and cancer. The recall covers all SynchroMed II pumps, with an estimated 261,109 devices implanted worldwide.

The recall is issued because of a potential for unintended delivery of drug during the priming bolus function. This malfunction can contribute to patient overdose or underdose symptoms, which may be clinically relevant. The agency has classified this as a Class I recall.

Healthcare professionals are being provided with safety information and patient management recommendations. Patients with these devices should consult their healthcare providers for guidance on managing the risk.

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. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Implantable Infusion Pump
Hazard: drug-overdose
drug-underdose
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 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

See all →

Moderate
Medtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
Moderate
Medtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
High
Medtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
Moderate
Neurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
High
Femoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31

Same hazard · drug overdose