Medtronic SmartSync Device Manager: False Electrical Reset Warning
Medtronic SmartSync Device Manager software displays a false electrical reset warning during device interrogation that could prompt unnecessary revision procedures. No actual reset occurs and the device functions normally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device software recall with documented adverse events—two unnecessary device explantation procedures resulted from clinician confusion about the false warning—though no device malfunction or patient injury from the device itself occurred.
Plain-English summary
Medtronic is recalling SmartSync Device Manager software, which is used to interrogate and manage cardiac implantable medical devices such as pacemakers and defibrillators.
The software displays a false warning message indicating that an electrical reset has occurred during device interrogation. In reality, no reset takes place and there are no changes to device parameters or loss of diagnostic data. As of April 30, 2025, Medtronic had received 39 reports of this display error. In two documented cases, the confusing warning prompted clinicians to perform unnecessary device explantation procedures.
This recall affects healthcare facilities and providers worldwide that manage patients with cardiac implantable devices using the SmartSync system. Clinicians should understand that a reset warning message does not indicate an actual device malfunction.
Medtronic has released updated software that eliminates the erroneous message. Affected healthcare providers should apply the software update to their SmartSync systems as soon as practicable.
The recalled product
- Product
- 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
- Manufacturer
- Medtronic, Inc.
- Hazard
- false-warning
- software-error
- diagnostic-confusion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Software Model Number
- D00U003
- GTIN 00763000002039
- Updated Software Version 6.5.5
- 2. Software Model Number
- D00U004
- GTIN 00763000002046
- 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
- 6. Software Model Number
- D00U008
Distribution
Distribution scope not specified by the agency.
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