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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96175

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

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Event summary

Timeline bucket
January 16, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Scientia Vascular, 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

Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.

Z-1235-2025
Recall number
Z-1235-2025
Initiated
January 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Scientia Vascular, Inc.
Quantity
1 unit

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.

Code information

Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300

Distribution pattern

U.S. Nationwide distribution in the state of DE.