Medtronic CareLink SmartSync Devices Abort Button Software Defect Limits Therapy Cancellation
Medtronic CareLink SmartSync Patient Connectors have a software defect where the Abort button operates only in a limited time window during induction tests, potentially preventing users from canceling high voltage therapy delivery.
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: This is an FDA Class II recall of a risk-of-harm medical device with a software defect limiting the ability to abort high voltage therapy delivery. No illnesses or injuries are reported in the source material, meeting the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic is recalling the CareLink SmartSync Patient Connector Model 24967 due to a software defect affecting the Abort button during induction tests. In prior software versions, the Abort button operates only within a limited time window, constraining users' ability to cancel high voltage therapy delivery once an induction test has commenced.
The recall affects 22,091 devices distributed worldwide, including throughout the United States. Multiple software versions are affected across several CareLink applications.
Patients and healthcare providers using affected devices should contact their healthcare provider or Medtronic for information about available solutions.
The recalled product
- Product
- Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software M
- Manufacturer
- Medtronic, Inc.
- Category
- Medical Device
- Hazard
- software-defect
- therapy-cancellation-risk
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
Distributed nationwide across the United States.
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