ARROW IPN033589Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902026149), received between Aug 4, 2023 and Dec 29, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K021723); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "THE 6 FR CATHETER WAS PLACED AND THE CATH-GARD WAS LOCKED ONTO THE SHEATH. A 5 FR CATHETER PLACED THROUGH THE CATH-GARD AND BLOOD QUICKLY STARTED LEAKING THROUGH THE HEMOSTASIS VALVE INTO THE CATH-GARD. THE CATHETER IN THE SHEATH WAS A PACING CATHETER. WHEN THE BLEEDING OCCURRED, AND PACING CATHETER AND CATH-GARD WERE REMOVED FROM THE SHEATH. A SEPARATE PACING CATHETER WAS INSERTED THROUGH THE SHEATH AND SECURED WITH ONLY A TEGADERM DRESSING. THE PATIENT WAS FINE POST THE PROCEDURE, THERE WAS NO PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 9680794-2025-01064 AND 9680794-2025-01063."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23904518 ↗
• MalfunctionOct 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "TRANSVENOUS PACER LINES WERE INTACT BEFORE AND AFTER REPOSITIONING PATIENT. POST REPOSITIONING, BLOOD AND SALINE FILLED THE CONTAMINATION SHIELD ON THE PACER WIRE AND LEAKING FROM THE DISTAL PART OF THE LINE. TTVP WIRE WAS REMOVED BY CATH LAB NURSE AND APPROPRIATE SIZED OBTURATOR CAP WAS APPLIED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."

  Patient problems: Fluid Discharge

  MAUDE report 20384160 ↗
• MalfunctionSep 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MULTIPLE ISSUES "ANECDOTALLY REPORTED" BY CARDIOLOGY AND ED THAT CONTAMINATION SHIELD NOTED TO BE MOIST AND FILLED WITH CLEAR FLUID. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17829401 ↗
• MalfunctionSep 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CONTAMINATION SHIELD WITH SHEATH ADAPTER FOR TEMPORARY VENOUS PACEMAKER WAS MOIST AND NOTED TO BE FILLED WITH CLEAR FLUID. THE SIDE PORT IS INFUSING WITH D5W AND INOTROPES. PATIENT IS STABLE HEMODYNAMICALLY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17828598 ↗
• MalfunctionAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  NOTIFICATION OF EVENT RECEIVED BY HEALTH CANADA REPORTS: "CODE BLUE RESPONSE SHEATH ADAPTER WITH CATH GUARD CONTAMINATION SHIELD USED ON 8.5 INTRODUCER WITH 5.0 FR TEMPORARY TRANSVENOUS PACEMAKER. 2 PART ADAPTER SYSTEM LEAKS BLOOD AND FLUID INTO SHIELD."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481082 ↗
• MalfunctionAug 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SYRINGE ASPIRATED AIR WHEN ASPIRATING THROUGH THE SIDE PORT OF THE SHEATH, WHILE PLACING A PACING-CATHETER ON THE PATIENT, WHICH INDICATED A LEAK IN THE CONTAMINATION SHIELD. THE PATIENT HAD NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17458250 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021723. One submission often covers many models, so check the product and lot details in each record.

• Z-2029-2018 · Apr 11, 2018 · Terminated
  Sheath Adapter with Cath-Gard Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847