Medtronic SynchroMed II and III Implantable Pumps Recalled for Software Defects
Medtronic is recalling SynchroMed II and III implantable pumps used with a clinician tablet app that has software issues in version 2.x. Approximately 319 systems were distributed worldwide.
What this means for you
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: FDA Class II recall of an implantable medical device. While no adverse events are reported in the source text, implantable pump software defects present inherent risk to dependent patients.
Plain-English summary
Medtronic Neuromodulation is recalling SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps when used with the PROG CT900B clinician tablet equipped with A810 CP app version 2.x. The recall was issued due to software issues identified in the application.
Approximately 319 systems with specific serial numbers were affected by this recall and distributed worldwide, including throughout the United States. The affected devices are identified by specific model numbers and serial number ranges.
Patients with these implantable pumps and their healthcare providers should contact Medtronic Neuromodulation directly for guidance on the identified software issues and any necessary corrective actions. Patients should consult with their healthcare provider before taking any action regarding their device to ensure the safest course of action.
The recalled product
- Product
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- Affected units
- 319
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 (2)
- GTIN: 00643169890947
- 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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