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Recall

Class II — Medtronic Inc.

Recalling firmMedtronic
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonMedtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
ProductCareLink 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.
Quantity33 units
DistributionNationwide Distribution to TN, MN, and WA
Initiated2016-08-05
Classified2016-09-27
Terminated2016-10-20
Recall numberZ-2898-2016
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Medtronic Inc. (Z-2898-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74955/

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