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AVANTI™+ Catheter Sheath Introducer

Cordis US Corp.

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Cordis US Corp.

  • Warning Letter 2011-02-16 Cordis LLC
  • VAI 2022-06-29 Cordis US Corp · 0 citations
  • VAI 2022-06-29 Cordis US Corp · 0 citations
  • VAI 2018-01-12 Cordis US Corp · 1 citations
  • VAI 2018-01-12 Cordis US Corp · 1 citations
  • VAI 2017-09-15 AccessClosure, Inc., A Cardinal Health Company · 1 citations
  • NAI 2016-07-06 Cordis US Corp · 0 citations
  • NAI 2016-07-06 Cordis US Corp · 0 citations
  • NAI 2016-03-31 Cordis US Corp · 0 citations
  • NAI 2016-03-31 Cordis US Corp · 0 citations
  • VAI 2016-02-12 Cardinal Health Mexico 244 S de RL de CV · 3 citations
  • NAI 2016-02-01 AccessClosure, Inc., A Cardinal Health Company · 0 citations
  • NAI 2015-05-08 Cordis US Corp · 0 citations
  • NAI 2015-05-08 Cordis US Corp · 0 citations
  • VAI 2014-08-05 AccessClosure, Inc., A Cardinal Health Company · 3 citations
  • NAI 2014-04-03 Cardinal Health Mexico 244 S de RL de CV · 0 citations
  • NAI 2014-01-30 Cordis US Corp · 0 citations
  • NAI 2014-01-30 Cordis US Corp · 0 citations
  • NAI 2013-12-18 Cordis US Corp · 0 citations
  • NAI 2013-12-18 Cordis US Corp · 0 citations
  • NAI 2012-07-03 Cordis US Corp · 0 citations