Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was recalled
Software issues were identified in application version 2.x.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide - US Nationwide distribution.
Recall record
- Recalling firm
- Medtronic Neuromodulation
- Product type
- Devices
- Recall number
- Z-0772-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Minneapolis, MN
- Recall initiated
- 2024-11-21
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0772-2025 · Source: openFDA enforcement.