Lower risk Medical device recall · FDA · Published June 17, 2025

Medtronic SmartSync Software Update Recalled: Erroneous Reset Message Risk

Medtronic recalls SmartSync Patient Connectors with specific software versions due to potential erroneous reset messages that could lead to unnecessary device explant. 39 reports of this error exist.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2127-2025Medical device Medtronic ›

Lower-risk recall

A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.

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Contact the company

Recalling firmMedtronic, Inc.8200 Coral Sea St Ne · Mounds View, MN 55112-4391

✎ GovInfoNow plain-language explainer

Medtronic is recalling SmartSync Patient Connectors with certain software versions because they may display a false reset message. This could cause doctors to unnecessarily remove the device, though no actual harm has occurred. The recall includes 39 reported cases of this issue. Read more at govinfonow.com/recall/52028-medtronic-smartsync-software-update-recalled-erroneous-reset-message-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52028-medtronic-smartsync-software-update-recalled-erroneous-reset-message-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2127-2025

Cite this page

“Medtronic SmartSync Software Update Recalled: Erroneous Reset Message Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/52028-medtronic-smartsync-software-update-recalled-erroneous-reset-message-risk. Based on FDA recall #Z-2127-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2127-2025%22&limit=1).

The FDA announced on June 17, 2025, that Medtronic, Inc. is recalling SmartLink Software loaded on SmartSync Patient Connector Model Number 24967. The software update eliminates the potential display of an erroneous electrical reset message during interrogation. Owners should obtain the available software update to correct this issue.

How to tell if you have it

Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967
UPC 00763000002039
UPC 00763000002046
UPC 00763000002053
UPC 00763000397852
UPC 00763000397869
UPC 00763000397876
UPC 00763000397883
UPC 00763000397890
UPC 00763000397906
UPC 00763000397913
UPC 00763000544300

The hazard

The erroneous message indicates an electrical reset has occurred, but no reset has actually happened and there are no parameter changes or loss of diagnostics. Prior to this software update, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through April 30, 2025.

Context

GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since September 10, 2017. Other recent recalls include the Medtronic Sphere-9 Catheter Recall (March 11, 2026), the Medtronic Abre Venous Stent Recall (December 4, 2025), and the Medtronic EVX 60 Series recall (October 29, 2025). Other recent recalls of similar products include the Medtronic Restore CP App Model A71100 Software Issue (November 20, 2025), the Philips Telemetry Monitor 5500 1.4 GHz Recall (June 5, 2026), and the GE Medical Systems Portrait Compute V1.2 Software Recall (July 20, 2026).

How to tell if you have this one

Check if your SmartSync Patient Connector has software model numbers D00U003 through D00U022 as listed in the recall notice. The device was sold with specific software versions that include the listed model numbers.

Brand
Medtronic
Product
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide

Recall number	Product, codes & lots	Quantity
Z-2127-2025	Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.; 1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; 3. Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; 4. Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; 5. Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.	3909 units
Z-2128-2025	Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.; 1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; 3. Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; 4. Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; 5. Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.	5418 units

Based on the official FDA remedy

What to do — step by step

Check Software Version
Review the software version on your device to see if it matches the listed versions in the recall notice.

How this recall unfolded

Recall timeline

FDA published this recall 36 days after the firm started it.

Jun 17, 2025Firm started the recall
Jul 17, 2025FDA classified it Class II
Jul 23, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52028-medtronic-smartsync-software-update-recalled-erroneous-reset-message-risk">Medtronic SmartSync Software Update Recalled: Erroneous Reset Message Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2127-2025 (June 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2127-2025 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.