Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported March 11, 2015
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 Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump mode
The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic MiniMed Inc. recalled CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application… - a low-severity action.
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application… was recalled by Medtronic MiniMed Inc. in March 11, 2015. Reason: The firm is informing customers of a software error that might result in an inaccurate display of the Temp Ba…. Check the official notice for the remedy. Verify recall #Z-1228-2015 with the FDA Devices before acting.
The recall
Medtronic MiniMed Inc. issued this low-severity FDA Devices recall-The firm is informing customers of a software error that might result in an inaccurate display of the Temp Ba….
- Low
- severity level
- Class III
- classification
- March 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1228-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1228-2015) was formally reported on March 11, 2015, with the manufacturer initiating the action on November 10, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Medtronic MiniMed Inc. is listed as the recalling firm, operating out of Northridge, CA. Federal records list the affected scope as 5 CareLink Pro 4.0 CD ROMs.
The documented reason for this recall is: The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pu… Distribution data in the federal record shows the product reached: Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5 CareLink Pro 4.0 CD ROMs
Related Recalls
6
3 from same agency
Product description
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 Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from the patient records for use in managing the patient's therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.
Reason for recall
The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1228-2015 |
| Date reported | March 11, 2015 |
| Date initiated | November 10, 2014 |
| Recalling firm | Medtronic MiniMed Inc. |
| Firm location | Northridge, CA |
| Affected scope | 5 CareLink Pro 4.0 CD ROMs |
| Distribution | Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International) |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1228-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from the patient records for use in managing the patient's therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.. Recalled by Medtronic MiniMed Inc.. Units affected: 5 CareLink Pro 4.0 CD ROMs.
Why was this product recalled? ▼
The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2015. Severity: Low. Recall number: Z-1228-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1228-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 11, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.