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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92930

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

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Event summary

Timeline bucket
August 01, 2023
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
SynCardia Systems 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

SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

Z-0126-2024
Recall number
Z-0126-2024
Initiated
August 01, 2023
Classification
Class II
Status
Completed
Recalling firm
SynCardia Systems LLC
Quantity
114 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.

Code information

All Lots/ UDI: 00858000003053

Distribution pattern

US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia