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Percutaneous Cavity Drainage Catheterization Set

Arrow International LLC (Subsidiary of Teleflex Incorporated)

UDILibrary device dossier · generated 2026-09-10 · 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 — Arrow International LLC (Subsidiary of Teleflex Incorporated)

  • VAI 2025-09-08 ARROW INTERNATIONAL, LLC · 2 citations
  • NAI 2023-07-14 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 0 citations
  • NAI 2023-07-14 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 0 citations
  • NAI 2021-06-16 Arrow International, Inc. (subsidiary of Teleflex, Inc.) · 0 citations
  • NAI 2021-06-16 Arrow International, Inc. (subsidiary of Teleflex, Inc.) · 0 citations
  • VAI 2016-06-20 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 1 citations
  • VAI 2016-06-20 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 1 citations
  • NAI 2016-03-17 Arrow International CR, a.s. · 0 citations
  • VAI 2016-03-10 Arrow Internacional De Chihuahua SA de CV · 3 citations
  • VAI 2014-09-24 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 0 citations
  • VAI 2014-09-24 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 0 citations
  • VAI 2014-08-22 Arrow International, Inc. (subsidiary of Teleflex, Inc.) · 10 citations
  • VAI 2014-08-22 Arrow International, Inc. (subsidiary of Teleflex, Inc.) · 10 citations
  • NAI 2014-05-08 Arrow International CR, a.s. · 0 citations
  • NAI 2013-12-18 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 0 citations
  • NAI 2013-12-18 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 0 citations
  • VAI 2013-11-07 Arrow International, Inc. (subsidiary of Teleflex, Inc.) · 1 citations
  • VAI 2013-11-07 Arrow International, Inc. (subsidiary of Teleflex, Inc.) · 1 citations
  • NAI 2013-02-07 Arrow International CR, a.s. · 0 citations
  • VAI 2012-02-01 Arrow International, Inc. (subsidiary of Teleflex, Inc.) · 1 citations