SynchroMed II and III implantable pumps recalled for software issues
Medtronic recalled SynchroMed II and III implantable pumps for software issues in the clinician tablet application. Fifty-nine systems are affected.
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 a Class II recall for software issues in an implantable drug-delivery system with no reported illnesses or injuries. Per the FDA rubric, it qualifies as a risk-of-harm product where no injury has yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Medtronic Neuromodulation has recalled SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps that are used with the PROG CT900C clinician tablet running A810 CP application version 2.x.
Software issues were identified in version 2.x of the A810 CP application. The recall involves 59 systems distributed nationwide and worldwide.
The recalled product
- Product
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- Affected units
- 59
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)
- GTIN: 00643169890961
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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