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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98633

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

Open FDA event record

Event summary

Timeline bucket
March 27, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Edwards Lifesciences, LLC

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

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Z-2172-2026
Recall number
Z-2172-2026
Initiated
March 27, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Edwards Lifesciences, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

Code information

All Lots/UDI:0690103D004EVD000V5

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Saudi Arabia, Germany, United Kingdom.