CLASS II Device recall · Reported 27 Apr 2016 · FDA Enforcement Report
CareLink iPro2 Reports recalled by Medtronic MiniMed
Medtronic MiniMed is recalling CareLink iPro2 Reports, distributed in Minnesota. The recall was initiated on 19 Feb 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1501-2016
- FDA event ID
- 73451
- Recalling firm
- Medtronic MiniMed, Northridge, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Feb 2016
- FDA classified
- 15 Apr 2016
- Reported
- 27 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 19 Feb 2016 | Recall initiated by company | |
| 15 Apr 2016 | Classified by FDA | +56 days |
| 27 Apr 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.
Product as listed by the FDA
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Where it was distributed
US: MN
Questions about this recall
Is CareLink iPro2 Reports recalled?
Yes. Medtronic MiniMed recalled CareLink iPro2 Reports on 19 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1501-2016.
Why was it recalled?
Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.
Which lots are affected?
n/a
Where was it sold?
US: MN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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