ARROW IPN918404Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902179323), received between Nov 19, 2025 and Sep 21, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K940079); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Material Separation

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 50841582 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT "STAINLESS STEEL NEEDLE DRIVER TIP BROKE OFF. CLINICIAN STATED THAT IT OCCURRED AFTER SUTURING WAS COMPLETED SO A NEW KIT WAS NOT NEEDED TO COMPLETE THE SECUREMENT. THE NEEDLE WAS SLIPPING DURING THE PROCEDURE BUT CLINICIAN WAS ABLE TO COMPLETE THE SUTURING WITHOUT ISSUE. THE NEEDLE DRIVER BROKE AFTER THE LAST PASS". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596700 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K940079. One submission often covers many models, so check the product and lot details in each record.

• Z-2385-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH;
• Z-1986-2018 · Apr 11, 2018 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8
• Z-1975-2018 · Apr 11, 2018 · Terminated
  Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-0990
• Z-2018-2018 · Apr 11, 2018 · Terminated
  ARROWgard Blue PLUS Multi-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: MSO-45703-AHS
• Z-2017-2018 · Apr 11, 2018 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWgard Blue Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903
• Z-1334-2018 · Dec 22, 2017 · Terminated
  Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
• Z-1160-2018 · Nov 14, 2017 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr
• Z-0784-2010 · Nov 24, 2009 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8
• Z-1492-2009 · Feb 11, 2009 · Terminated
  Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers
• Z-1035-03 · Jul 8, 2003 · Terminated
  9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath