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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91260

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

Open FDA event record

Event summary

Timeline bucket
November 21, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic MiniMed

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

Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

Z-0776-2023
Recall number
Z-0776-2023
Initiated
November 21, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
3235

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.

Code information

App Version 1.3.0

Distribution pattern

OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom