Z-0137-2025Class II

SynchroMed II Infusion Pump. Product Number: 8637-20

Name: Z-0137-2025 SynchroMed II Infusion Pump. Product Number: 8637-20
Creator: Medtronic Neuromodulation
Published: 2024-09-11
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2024-09-11 / Open, Classified / root cause: design

FDA source

Medtronic Neuromodulation began a recall of SynchroMed II Infusion Pump. Product Number: 8637-20 on 2024-09-11. FDA classified it as Class II and gives the reason as "Potential for error and inability to interrogate pump due to data corruption in the pump memory". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0137-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-11
Posted: 2024-10-21
Recalling firm: Medtronic Neuromodulation
Product: SynchroMed II Infusion Pump. Product Number: 8637-20
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Root cause tag: design
FDA root cause: Device Design
Action: On 11-September-2024, a Medtronic representative was sent to the physician s facility where the representative provided the communication and confirmation form to the physician. The physician was asked to sign the confirmation form indicating they read the notification. The representative reset the patient s pump.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of Mississippi.
Product codes and lots: GTIN Number: 00643169630505. Serial Number: NGP004814H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0137-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0137-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-21

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)