ARROW IPN033600Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801902101624), received between Aug 30, 2024 and Feb 4, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT: "USER COMPLAINT THAT AFTER PUTTING AN AI-07155 TEMP PACING CATHETER THROUGH THE SI-09600, THE VALVE FROM SI-09600 HAD BACK BLEEDING, USER CHANGED TO USE ANOTHER SAME LOT OF SI-09600 BUT THERE WAS A SAME ISSUE HAPPENED AGAIN. THE PATIENT WAS REPORTED AS FINE." ASSOCAITED COMPLAINTS 9680794-2026-00062 AND 9680794-2026-00055.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256536 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT: "USER COMPLAINT THAT AFTER PUTTING AN AI-07155 TEMP PACING CATHETER THROUGH THE SI-09600, THE VALVE FROM SI-09600 HAD BACK BLEEDING, USER CHANGED TO USE ANOTHER SAME LOT OF SI-09600 BUT THERE WAS A SAME ISSUE HAPPENED AGAIN. THE PATIENT WAS REPORTED AS FINE." ASSOCAITED COMPLAINTS 9680794-2026-00062 AND 9680794-2026-00055.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256532 ↗
• InjuryMar 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE TEMPORARY PACEMAKER REQUIRED REMOVAL DUE TO AN MRI PROCEDURE. ELECTROPHYSIOLOGY PROCEEDED WITH CHANGING THE INTRODUCER, AS THE INITIAL 8.5 FR INTRODUCER ALLOWED BLOOD TO RETURN TO THE PACEMAKER PROTECTOR. A 6.0 FR INTRODUCER WAS USED INSTEAD, BUT IT WAS LATER OBSERVED THAT BLOOD RETURN PERSISTED, AND NO SMALLER RF WAS AVAILABLE. THE PATIENT, BEING COMPLETELY DEPENDENT ON THE PACEMAKER, REMAINED UNDER OBSERVATION. FOLLOWING AN INFLAMMATORY RESPONSE, BLOOD CULTURES IDENTIFIED ENTEROCOCCUS FAECALIS, AND ANTIBIOTIC-COATED TREATMENT WAS INITIATED.

  Patient problems: Bacterial Infection

  MAUDE report 21584901 ↗
• MalfunctionNov 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "DURING TRANSVENOUS PACEMAKER IMPLANTATION, THE INTRODUCER HAS NO MEMBRANE, WHICH CAUSES ABUNDANT BLOOD TO LEAK OUT OF THE UPPER END(REFERENCE IS MADE TO THE PORT THROUGH WHICH THE DILATOR IS INTRODUCED). A NEW DEVICE IS USED (A NEW INTRODUCER IS OPENED)." 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 20640917 ↗
• MalfunctionAug 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "A FIRST PLACEMENT ATTEMPT IS MADE WITH REFERENCE SI-09600, LOT 14F21L0107, INSERTING THROUGH THE RIGHT SUBCLAVIAN VEIN. UPON INSERTING THE TEMPORARY TRANSVENOUS PACEMAKER, THE GUIDEWIRE IS ADVANCED APPROXIMATELY HALFWAY; HOWEVER, RESISTANCE IS ENCOUNTERED, AND THE GUIDEWIRE IS REMOVED, REVEALING IT IS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20105117 ↗

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