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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74955

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 05, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2898-2016
Recall number
Z-2898-2016
Initiated
August 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic Inc.
Quantity
33 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software due to a time stamp error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

n/a

Distribution pattern

Nationwide Distribution to TN, MN, and WA