ARROW IPN030345Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801902102867), received between Apr 23, 2021 and Jun 23, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

17 other recalls cover devices cleared under the same FDA submission (K780532); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE SWG WAS KINKED DURING USE. THEREFORE, A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310065 ↗
• MalfunctionJan 13, 2025Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  IT WAS REPORTED THAT: "THE TYVEK OF THE KIT WAS FOUND TORN UPON DELIVERY. THEREFORE, A NEW KIT WAS USED INSTEAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21135438 ↗
• MalfunctionAug 12, 2021Leak/Splash; Leak/Splash

  CUSTOMER REPORTED DURING THE REMOVAL OF THE CATHETER, THE SHEATH VALVE DID NOT WORK AND AIR LEAKED INSIDE. THE AIR WAS QUICKLY REMOVED WITH A SYRINGE AND THE DEVICE WAS REMOVED QUICKLY. NO PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315586 ↗
• MalfunctionApr 23, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: THE CATHETER WAS WITHDRAWN BY THE DOCTOR IN THE "ZVD POSITION" BECAUSE THE PATIENT HAD TO GO TO MRI. THE DOCTOR WANTED TO "DISCONNECT THE CATHETER WITH THE BLUE LOCK" AND THERE WAS SOME RESISTANCE, "BUT NO MORE THAN USUAL" AND PART OF THE SHEATH TORE OFF THE CATHETER. THE SHEATH WAS CLOSED SO THAT "NO AIR COULD BE SUCKED IN WHEN THE PATIENT WAS VENTILATED" AND THEN THE SHEATH WAS REMOVED IMMEDIATELY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K780532. 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-1242-2020 · Dec 20, 2019 · Terminated
  Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
• Z-2576-2018 · May 23, 2018 · Terminated
  Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introduc
• Z-2031-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
• Z-1976-2018 · Apr 11, 2018 · Terminated
  Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
• Z-1977-2018 · Apr 11, 2018 · Terminated
  Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
• Z-2011-2018 · Apr 11, 2018 · Terminated
  Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
• Z-2032-2018 · Apr 11, 2018 · Terminated
  9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-0
• Z-1329-2018 · Dec 22, 2017 · Terminated
  (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Nu
• Z-1158-2018 · Nov 14, 2017 · Terminated
  Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits ven
• Z-1287-2018 · Oct 26, 2017 · Terminated
  Arterial Access Tray, introducer catheter; Model: GU-04020
• Z-2329-2017 · May 9, 2017 · Terminated
  1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
• Z-0066-2015 · Aug 6, 2014 · Terminated
  Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
• Z-1713-2014 · Apr 14, 2014 · Terminated
  Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
• Z-0468-2014 · Oct 9, 2013 · Terminated
  Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and thera

…and 2 more.