AngioDynamics 18100201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787181002010), received between Oct 31, 2022 and Oct 31, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K780126); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PER THE CATH LAB TEAM, THE STEMI AND TEMP PACER INSERTION PROCEDURE WAS COMPLETED ANDAN ARNOLD SHEATH FROM AN ARNOLD INTRO SET 6F WAS SUTURED IN PLACE BY A SCRUB TECHNICIAN. THE PATIENT BEGAN COUGHING AND THE SHEATH'S SUTURE EYELET SLIT, CAUSING THE SHEATH AND PACING WIRE TO BE PULLED BACK. ONLY ONE SUTURE HAD BEEN USED IN THE EYELET. THE PATIENT"S COUGHING AND A LARGE HERNIA EXERTING PRESSURE ON THE EYELET WERE BELIEVED TO CONTRIBUTE TO THE EVENT. THE PATIENT REQUIRED BRIEF 20 SECONDS OF CPR AND NEW SHEATH AND PACING WIRE INSERTED." IT WAS REPORTED THE PATIENT HAS SINCE BEEN DISCHARGED.

  Patient problems: Cardiac Arrest

  MAUDE report 15700266 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K780126. One submission often covers many models, so check the product and lot details in each record.

• Z-2705-2026 · Jun 1, 2026 · Open, Classified
  One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
• Z-2806-2020 · Jun 19, 2020 · Terminated
  ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or
• Z-1938-2020 · Apr 8, 2020 · Terminated
  PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedu
• Z-1029-2016 · Feb 17, 2016 · Terminated
  ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and
• Z-0764-2010 · Jan 6, 2009 · Terminated
  Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA f