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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 implanta
- 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 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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