Medtronic CareLink Pro Software Recall for Inaccurate Basal Data Display
Medtronic MiniMed is recalling CareLink Pro and CareLink Clinical software due to a defect that may cause inaccurate display of Temp Basal time and duration in reports.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The source text describes a software display error without reporting any injuries or illnesses.
Plain-English summary
Medtronic MiniMed Inc. is recalling CareLink Pro (MMT-7335) and CareLink Clinical (MMT-7334) software applications. These products are personal computer software and network-based systems designed to help healthcare providers manage diabetic patients using Medtronic insulin pumps and blood glucose meters. The recall involves 5 CareLink Pro 4.0 CD ROMs and the associated Clinical software model.
The recall is being issued because of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports. This issue specifically affects data uploaded from the MiniMed 620G or 640G insulin pumps. The source text does not report any illnesses, injuries, or deaths associated with this software error.
The affected products were distributed worldwide to Japan only. CareLink Clinical is intended for use in clinical trials in the US and internationally. Healthcare providers and customers using these software applications to manage patient therapy should be aware that Temp Basal data in their reports may be displayed incorrectly.
The recalled product
- Product
- CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care…
- Manufacturer
- Medtronic MiniMed Inc.
- Category
- Medical Device — Software
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 (1)
- Medtronic MiniMed CareLink Pro 4.0 model MMT-7335WWP and Clinical model MMT-7334
Distribution
Distribution scope not specified by the agency.
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