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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69799

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

Open FDA event record

Event summary

Timeline bucket
November 13, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Concentric Medical Inc

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

Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Z-0528-2015
Recall number
Z-0528-2015
Initiated
November 13, 2013
Classification
Class II
Status
Terminated
Recalling firm
Concentric Medical Inc
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.

Code information

Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015

Distribution pattern

US Distribution to states of: CA, IN, PA, AL, and NJ.