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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88089

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

Open FDA event record

Event summary

Timeline bucket
May 14, 2021
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

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

Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only

Z-2076-2021
Recall number
Z-2076-2021
Initiated
May 14, 2021
Classification
Class II
Status
Ongoing
Quantity
21,685

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.

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

Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.

Code information

Model Number: LNQ22

Distribution pattern

Worldwide distribution - US Nationwide in the states of AK, AL, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The countries of Australia, Austria, Canada, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Netherlands Antilles, Sweden, Switzerland, and United Kingdom.