Medtronic SynchroMed II Programmable Pump May Fail to Resume Drug Delivery After MRI
The Medtronic SynchroMed II pump may fail to resume medication delivery after an MRI scan if the device switches to telemetry mode due to electromagnetic interference while alarming. The pump will not resume normal operation after leaving the MRI magnetic field.
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: This is an FDA Class II recall of a drug-delivery device with a confirmed failure mode (inability to resume medication delivery after MRI exposure), qualifying as a risk-of-harm product. However, the source text does not report any illnesses or injuries to date, which per the rubric limits this to a maximum score of 3.
Plain-English summary
Medtronic is recalling the SynchroMed II, Model 8637-40, a programmable infusion pump for drug delivery. Approximately 78,532 units have been distributed worldwide. When the pump is exposed to electromagnetic interference from an MRI scan while the device is sounding an alarm, the pump may switch into telemetry mode. In this condition, the pump will not resume drug delivery after leaving the MRI magnetic field.
This failure is inconsistent with the pump's current labeling. Patients who depend on this pump for medication delivery and undergo MRI procedures may experience an unintended interruption of drug delivery if the device does not resume normal operation.
Patients with this pump should discuss MRI procedures with their healthcare providers before undergoing any such procedures. Healthcare providers should review the recall details and affected serial numbers to determine if a patient's device is included in the recall. Clinical measures should be considered to protect patients who require continuous medication delivery.
The recalled product
- Product
- Medtronic SynchroMed II, Model 8637-40, Programmable pump
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 78,532
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 (20)
- GTIN 00613994483195
- Serial Numbers: NGV502657H
- NGV508302H
- NGV612281H
- NGV612282H
- NGV717221H
- NGV723564H
- NGV727392H
- NGV727397H
- NGV727400H
- NGV727906H
- NGV730310H
- NGV741180H
- GTIN 00643169100824
- Serial Numbers: NGV503518H
- NGV503522H
- NGV504577H
- NGV504580H
- NGV504581H
- NGV507269H
Distribution
Distribution scope not specified by the agency.
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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