Medtronic Implantable Drug Pumps Recalled for Software Defects
Medtronic has recalled 566 SynchroMed II and III implantable drug infusion pumps due to software issues in the controlling application. No injuries or illnesses have been reported.
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 affecting an implantable medical device used to deliver life-sustaining medications. Although no adverse events or illnesses have been reported, a software defect in drug delivery systems represents a risk-of-harm to patients. According to the severity rubric, risk-of-harm products where injury has not yet been reported merit a High (3) severity score.
Plain-English summary
Medtronic Neuromodulation is recalling 566 SynchroMed II (Model 8637) and SynchroMed III (Model 8667) implantable drug infusion pumps used with the PROG CT900D Clinician Tablet running A810 CP application version 2.x. These pumps deliver medication directly into patients' bodies for pain management and other chronic conditions.
Software issues were identified in application version 2.x. No injuries, illnesses, or adverse events have been reported in connection with this recall.
The affected devices were distributed worldwide, including throughout the United States. A total of 566 specific device serial numbers are identified in this recall.
Patients and healthcare providers with affected devices should contact Medtronic for information about their specific pump and instructions for remediation.
The recalled product
- Product
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- Affected units
- 566
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: 00763000094027 00763000077730 00763000421007 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighFemoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
Same hazard · software defect
See all →- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateMedtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump
FDA (Devices) · 2017-04-05
- SevereMedtronic SynchroMed II Software Card Recall for Priming Bolus Function
FDA (Devices) · 2017-03-08
- HighMedtronic Recalls SynchroMed II Implantable Pumps Due to Alarm Failure
FDA (Devices) · 2015-06-03
- HighMedtronic Recalls Unimplanted SynchroMed II Pumps Due to Motor Stall Risk
FDA (Devices) · 2018-03-14
- SevereMedtronic SynchroMed II Implantable Pumps Recalled for Overinfusion Risk
FDA (Devices) · 2014-05-14
- CriticalMedtronic SynchroMed II Pump Recall for Unintended Drug Delivery
FDA (Devices) · 2013-07-03