Data Foundry

Medical device recalls 2016

CareLink iPro Version 1 — Class II medical device recall Z-2898-2016

Terminated recall by Medtronic Inc., reported 2016-10-05, distributed nationwide. Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

Recall numberZ-2898-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedtronic Inc., Northridge, CA, United States
Recall initiated2016-08-05
Classified2016-09-27
Reported by FDA2016-10-05
Terminated2016-10-20
DistributedNationwide (US)
Quantity33 units
Reason classessoftware
Model numbersMMT-7340

Product

CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

Reason for recall

Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2898-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.