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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81300

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 02, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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

2 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 2

Medtronic CareLink 2090 Programmer

Z-0406-2019
Recall number
Z-0406-2019
Initiated
October 02, 2018
Classification
Class II
Status
Ongoing
Quantity
30172 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

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

Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

Code information

All Serial Numbers

Distribution pattern

Worldwide

device · product 2 of 2

Medtronic CareLink Encore 29901 Programmer

Z-0407-2019
Recall number
Z-0407-2019
Initiated
October 02, 2018
Classification
Class II
Status
Ongoing
Quantity
4072 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

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

Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

Code information

All Serial Numbers

Distribution pattern

Worldwide