CLASS II ONGOING Device recall · Reported 8 Jan 2025 · FDA Enforcement Report
SynchroMed II recalled by Medtronic Neuromodulation
Medtronic Neuromodulation is recalling SynchroMed II, distributed nationwide in the US. The recall was initiated on 21 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0772-2025
- FDA event ID
- 95845
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Nov 2024
- FDA classified
- 27 Dec 2024
- Reported
- 8 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 21 Nov 2024 | Recall initiated by company | |
| 27 Dec 2024 | Classified by FDA | +36 days |
| 8 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software issues were identified in application version 2.x.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
Software issues were identified in application version 2.x.
Which lots are affected?
GTIN: 00643169890961; Serial Numbers: NPL1000442 NPL1000448 NPL1000453 NPL1000765 NPL1000776 NPL1000797 NPL1000809 NPL1000810 NPL1000811 NPL1000813 NPL1000814 NPL1000815 NPL1000817 NPL1000818 NPL1000819 NPL1000827 NPL1000830 NPL1000834 NPL1000835 NPL1000858 NPL1001552 NPL1001558 NPL1001564 NPL1001566 NPL1001574 NPL1001583 NPL1001590 NPL1001591 NPL1001592 NPL1001594 NPL1001595 NPL1001601 NPL1001608 NPL1001615 NPL1001620 NPL1001629 NPL1001630 NPL1001631 NPL1001650 NPL1001651 NPL1001656 NPL1001670 NPL1001675 NPL1002257 NPL1002259 NPL1002260 NPL1002264 NPL1002265 NPL1002266 NPL1002267 NPL1002281 NPL1002282 NPL1002284 NPL1002286 NPL1002288 NPL1002295 NPL1002297 NPL1002308 NPL1002309
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95845This product is part of a recall event; the main page for the event is SynchroMed II recalled by Medtronic Neuromodulation.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SynchroMed II recalled by Medtronic Neuromodulation | Medtronic Neuromodulation | Device Malfunction | Nationwide | |
| CLASS II | SynchroMed II recalled by Medtronic Neuromodulation | Medtronic Neuromodulation | Device Malfunction | Nationwide | |
| CLASS II | SynchroMed II recalled by Medtronic Neuromodulation | Medtronic Neuromodulation | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | A71200 Vanta" Clinician Programmer Application (CP App) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
| Device | CLASS II | Restore Clinician Programmer Application (CP App) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
| Device | CLASS II | Enhanced Verify Evaluation Handset (CFN HH90130FA) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |