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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73183

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

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Event summary

Timeline bucket
December 31, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cordis Corporation

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

CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.

Z-1174-2016
Recall number
Z-1174-2016
Initiated
December 31, 2015
Classification
Class II
Status
Terminated
Recalling firm
Cordis Corporation
Quantity
1,985 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect cannula of the sheath introducer (smaller than intended).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect cannula of the sheath introducer (smaller than intended).

Code information

Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580, Expiration date: 2018-07-31.

Distribution pattern

US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii.

Field note

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