SynchroMed II and III Implantable Pumps Recalled for Software Issues
Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.
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 FDA recall of implantable pumps with identified software defects. Although no injuries or illnesses have been reported, implantable medical devices with software issues pose inherent risk of harm through potential device malfunction. This fits the rubric category of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medtronic Neuromodulation has recalled SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps. This recall affects approximately 3,981 systems distributed worldwide, including throughout the United States.
Software issues have been identified in application version 2.x of the PROG CT900E Clinician Tablet software. This software application is used to program and manage the implantable pumps. The FDA classified this recall as Class II.
Patients with these implanted devices and healthcare providers using the affected software may be impacted. Specific serial numbers of affected devices are provided in the official FDA recall notice.
Patients should contact their healthcare provider or Medtronic to determine if their device is affected and to discuss appropriate follow-up care.
The recalled product
- Product
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 3,981
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: 00763000447090 00763000729141 00763000737290 00763000447090
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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