Medtronic Recalls SynchroMed II Implantable Pumps Due to Alarm Failure
Medtronic is recalling specific SynchroMed II implantable drug pumps because the audible alarm may stop working, potentially preventing patients from detecting issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 product (implantable medical device) where the failure of a safety alarm could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Medtronic Neuromodulation is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps. The recall is being issued because the audible alarm on these devices could cease to function.
The SynchroMed II pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site in the body. The affected units are sterile and were distributed worldwide, including in the United States and various international markets.
Patients with these specific implantable pumps should contact their healthcare provider or Medtronic for instructions on how to proceed. The recall is focused on the potential failure of the audible alarm, which is a safety feature designed to alert users to device status.
The recalled product
- Product
- Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted…
- Manufacturer
- Medtronic Neuromodulation
- Hazard
Distribution
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