ARROW IPN033616Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902101709), received between Jun 29, 2022 and Aug 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT (B)(6) 2025, THE DOCTOR FOUND THE PACKAGE DAMAGED PRIOR TO THE PATIENT." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828175 ↗
• MalfunctionNov 13, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT "THE EVENT OCCURRED DURING THE PLACEMENT OF THE DEVICE. THE CATHETER WAS NECESSARY TO INTRODUCE A SWAN GANZ (PATIENT IN CARDIOGENIC SHOCK). THE PLACER HAS A LOT OF EXPERIENCE AND SHE PLACED THE CATHETER ACCORDING TO THE IFU (SHE USED THE DILATOR CORRECTLY), THEN SHE TRIED TO MOVE FURTHER THE SHEATH AND IT COMPLETELY GOT CURLED. SHE THEN LEFT THE GUIDEWIRE IN PLACE AND SHE TOOK A NEW INTRODUCER AND THE PROCEDURE WAS SUCCESSFUL THIS TIME. WHEN IT COMES TO THE PATIENT, HE DECEASED 1 DAY LATER. PLACER CLEARLY STATES THERE IS NO CAUSAL LINK WITH THIS INCIDENT.".

  Patient problems: Insufficient Information

  MAUDE report 20677273 ↗
• MalfunctionJun 29, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THE INSERTION OF THE SHEATH WAS WITHOUT PROBLEM. A SLIGHT RESISTANCE WAS FELT WHEN PULLING BACK THE GUIDEWIRE. IT WAS NOTICIED THE GUIDEWRIE HAD UNRAVELLED AND THE SHEATH AND GUIDEWIRE WERE IMMEDIATELY REMOVED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14858975 ↗

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-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-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-2011-2018 · Apr 11, 2018 · Terminated
  Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
• 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-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.