Class II recallOngoing

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer recall — FDA event 98750

FDA · FDA event 98750 · Posted May 14, 2026

Published May 14, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 4/8/2026 via email and mail. The notice explained the issue with the device and provided the following: "Recommendations: Review the order of Flex Infusion steps for patients previously programmed in Flex Infusion Mode: Review the Session Report from the prior interrogation. Access the report via the A810 application by communicating with the pump, then navigating to Settings > Reports > Session Long Report, and review the patient s previous programming session. Within Current Settings, confirm that the steps and durations are listed in the correct chronological order. If steps are not in chronological time order, either change the timing of the steps so they appear in order or reprogram while adding steps in chronological time order. When programming in Flex Infusion mode: Program Flex Infusion steps in chronological order. Before completing programming, confirm on the Finish screen that all steps appear in chronological time order (earliest to latest). If steps are not in chronological time order, reorder. Actions: Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com." For questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer by Medtronic, Inc..

Products affected by FDA event 98750
Model	Description	Lot / serial range	Manufactured	Status
Z-2201-2026	Z-2201-2026	Software application (app) version 1.x and 2.x, loaded on the following units: 1. Model Number CT900A, GTIN 00643169890923, Serial Numbers: NPL0004445; 2. Model Number CT900B, GTIN 00643169890947, Serial Numbers: NPL1000042, NPL1000045, NPL1000046, NPL1000048, NPL1000050, NPL1000051, NPL1000053, NPL1000054, NPL1000059, NPL1000060, NPL1000062, NPL1000065, NPL1000069, NPL1000070, NPL1000071, NPL1000072, NPL1000073, NPL1000074, NPL1000075, NPL1000077, NPL1000081, NPL1000082, NPL1000083, NPL1000085, NPL1000086, NPL1000087, NPL1000090, NPL1000091, NPL1000093, NPL1000094, NPL1000098, NPL1000117, NPL1000133, NPL1000135, NPL1000137, NPL1000138, NPL1000151, NPL1000159, NPL1000160, NPL1000164, NPL1000166, NPL1000167, NPL1000169, NPL1000173, NPL1000174, NPL1000179, NPL1000180, NPL1000183, NPL1000185, NPL1000186, NPL1000187, NPL1000188, NPL1000191, NPL1000192, NPL1000193, NPL1000194, NPL1000195, NPL1000196, NPL1000230, NPL1000235, NPL1000237, NPL1000242, NPL1000244, NPL1000245, NPL1000246, N	Not provided in the normalized record	Ongoing

Distribution: Worldwide distribution.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Apr 8, 2026
Recall initiated
Date recorded by the FDA.
May 14, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 98750
Published: May 14, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

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Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer recall — FDA event 98750

FDA · FDA event 98750 · Posted May 14, 2026

Published May 14, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

This FDA record lists Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer by Medtronic, Inc..

Products affected by FDA event 98750
Model	Description	Lot / serial range	Manufactured	Status
Z-2201-2026	Z-2201-2026	Software application (app) version 1.x and 2.x, loaded on the following units: 1. Model Number CT900A, GTIN 00643169890923, Serial Numbers: NPL0004445; 2. Model Number CT900B, GTIN 00643169890947, Serial Numbers: NPL1000042, NPL1000045, NPL1000046, NPL1000048, NPL1000050, NPL1000051, NPL1000053, NPL1000054, NPL1000059, NPL1000060, NPL1000062, NPL1000065, NPL1000069, NPL1000070, NPL1000071, NPL1000072, NPL1000073, NPL1000074, NPL1000075, NPL1000077, NPL1000081, NPL1000082, NPL1000083, NPL1000085, NPL1000086, NPL1000087, NPL1000090, NPL1000091, NPL1000093, NPL1000094, NPL1000098, NPL1000117, NPL1000133, NPL1000135, NPL1000137, NPL1000138, NPL1000151, NPL1000159, NPL1000160, NPL1000164, NPL1000166, NPL1000167, NPL1000169, NPL1000173, NPL1000174, NPL1000179, NPL1000180, NPL1000183, NPL1000185, NPL1000186, NPL1000187, NPL1000188, NPL1000191, NPL1000192, NPL1000193, NPL1000194, NPL1000195, NPL1000196, NPL1000230, NPL1000235, NPL1000237, NPL1000242, NPL1000244, NPL1000245, NPL1000246, N	Not provided in the normalized record	Ongoing

Distribution

Worldwide distribution.

Units affected

See official FDA record

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer recall — FDA event 98750

Follow Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer recall — FDA event 98750

Follow Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline