Z-0522-2024Class II

Medtronic SynchroMed, Model A10

Name: Z-0522-2024 Medtronic SynchroMed, Model A10
Creator: Medtronic Inc.
Published: 2020-07-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-07-13 / Completed / root cause: software

FDA source

Medtronic Inc. began a recall of Medtronic SynchroMed, Model A10 on 2020-07-13. FDA classified it as Class II and gives the reason as "The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-0522-2024
Classification: Class II
Status: Completed
Initiated: 2020-07-13
Posted: 2023-12-09
Recalling firm: Medtronic, Inc.
Product: Medtronic SynchroMed, Model A10
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
Root cause tag: software
FDA root cause: Software Design Change
Action: Medtronic issued a SAFETY NOTIFICATION to its consignees on 07/13/2020 by letter. The notice explained the problem with the device and requested the software be upgraded to version 1.1.342.
Quantity in commerce: 2543 units
Distribution: Foreign Distribution
Product codes and lots: GTIN 00643169771031, All serial numbers with software version 1.1.300.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0522-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0522-2024	Class II	Completed	Voluntary: Firm initiated	2023-12-20	2023-12-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)