ARROW IPN030348Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801902102874), received between Jun 4, 2024 and Jan 6, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT: "(B)(6) 2025, DURING THE PLACEMENT OF PRODUCT, BLOOD LEAKAGE WAS OBSERVED BOTH INSIDE AND OUTSIDE THE SHEATH PROTECTIVE SLEEVE, RESULTING IN CONTAMINATION OF THE PULMONARY ARTERY CATHETER (PAC) AND RENDERING IT UNUSABLE, WHICH DELAYED THE TREATMENT TIME." ASSOCIATED COMPLAINTS 3006425876-2026-00016 AND 3006425876-2026-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971769 ↗
• MalfunctionJan 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT: " ON (B)(6) 2025, DURING THE PLACEMENT OF PRODUCT, BLOOD LEAKAGE WAS OBSERVED BOTH INSIDE AND OUTSIDE THE SHEATH PROTECTIVE SLEEVE, WHICH DELAYED THE TREATMENT TIME. INVOLVED 1 PC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943815 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "(B)(6) 2025, AFTER INSERTION FROM RIGHT INTERNAL JUGULAR VEIN, WHEN A FLOATING CATHETER FOR PULMONARY ARTERY WAS PLACED FROM THE SHEATH, THE BLOOD WAS FOUND TO BE LEAKING OUT OF THE PROTECTIVE MEMBRANE OF THE FLOATING CATHETER, SO THE CATHETER AND THE SHEATH WERE REMOVED, AND PRESSURE WAS APPLIED TO STOP THE HEMORRHAGE." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22642232 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "ON (B)(6) 2025, THE DOCTOR FOUND SHEATH BODY DAMAGED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412908 ↗
• MalfunctionJun 11, 2025Fluid/Blood Leak; Failure to Seal; Fluid/Blood Leak; Failure to Seal

  IT WAS REPORTED "PATIENT WHO IS PLACED WITH A TEMPORARY PACEMAKER AND DOES NOT SEAL THE VALVE, ALLOWING BLOOD TO PASS THROUGH THE SHEATH." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186789 ↗
• MalfunctionApr 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE INJECTION OF SALINE SOLUTION REVEALED THAT THERE WAS LIQUID LEAKAGE AT THE WHITE SEALED CONNECTOR." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21813788 ↗
• InjuryFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "UNDERGOING TAVI PROCEDURE IN OPERATION THEATRE. USING A 7.5 FR SWAN GANZ CATHETER. LEAKING HAPPENS DURING THE CASE. INTERFERE WITH THE PROCEDURE, NEED TO USE GAUZE, PLASTER, AND TAPE TO SLOW DOWN THE LEAK. ALSO, PATIENT NEED BLOOD TRANSFUSION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404207 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT" (B)(6) 2024, THE CATHETER WAS FOUND TO BE LEAKING DURING USE ON THE PATIENT. INVOLVED 1 PC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062768 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "(B)(6) 2024, THE CATHETER WAS FOUND LEAKING DURING USE ON THE PATIENT. INVOLVED 1 PC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062755 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SPRING-WIRE GUIDE BENDS AND CANNOT BE PLACED SMOOTHLY". THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". IT WAS REPORTED, THE ALLEGED DEFECT DID NOT CONTRIBUTE TO THE PATIENT'S DEATH BUT CAUSED A DELAY TO THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 19461697 ↗

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-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-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-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.