ARROW IPN000096 (REF AI-07155-KS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902004533), received between Oct 25, 2023 and Aug 25, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K945229); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Intermittent Capture; Fluid/Blood Leak; Loose or Intermittent Connection; Migration

  Patient problems: Arrhythmia; Insufficient Information

  MAUDE report 50422578 ↗
• InjuryJul 30, 2026Fluid/Blood Leak

  It was reported that in the CVICU, nursing staff observed intravenous fluid and blood leaking into the Cath-Gard contamination shield while the temporary transvenous pacing (TVP) system was in use. The TVP had been in place for approximately 24 hours when the issue was identified and was subsequently removed on (b)(6)2026. The patient experienced an unknown amount of blood loss; however, no blood transfusion or administration of blood products was reported. It was further reported that the patient became febrile and was subsequently diagnosed with a central line-associated bloodstream infection (CLABSI). The patient received intravenous antibiotic treatment from (b)(6)2026 through (b)(6)2026. The patient subsequently underwent permanent pacemaker placement(PPM) and was discharged home on (b)(6)2026, with a subsequent discharge reported on (b)(6)2026. No additional medical or surgical interventions were reported beyond those described above.

  Patient problems: Bacteremia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50088596 ↗
• MalfunctionFeb 24, 2026Material Integrity Problem

  IT WAS REPORTED " THE BIGGEST PROBLEM IS THE TUOHY THAT IS SUPPOSED TO TIGHTEN ONTO THE PACING CATHETER DOES NOT GET TIGHT ENOUGH TO KEEP THE CATHETER IN PLACE, WHICH ALLOWS THE CATHETER TO MOVE WITH MINIMAL EFFORT. BLOOD BACKUP INTO THE SWANDOM ALMOST IMMEDIATELY AFTER PLACEMENT AND CONTINUED AFTER CHECKING THE TUOHY WAS AS TIGHT AS POSSIBLE. ONCE A PRESSURE BAG WAS HOOKED UP TO THE ONE PATIENT, THE ENTIRE SWANDOM FILLED WITH FLUID (IT WAS DESCRIBED AS LOOKING LIKE A LONG WATER BALLOON). THE PATIENT DID FINE UNTIL THE NEXT DAY; WE GOT LUCKY THAT THE CATHETER DIDN'T MOVE ENOUGH THAT IT STOPPED CAPTURING".

  Patient problems: Insufficient Information

  MAUDE report 24429354 ↗
• MalfunctionFeb 23, 2026Material Integrity Problem

  IT WAS REPORTED " THE LOCKING MECHANISM, EVEN WHEN FULLY TIGHTENED, DOES NOT SECURE THE PACING WIRE IN PLACE. WE'VE ALSO NOTICED THAT BLOOD/FLUID BACKS UP INTO THE SWANDOM ALMOST IMMEDIATELY AS WELL. WE HAD A PATIENT YESTERDAY, WHO BY THE TIME THEY GOT UP TO THEIR ROOM, WAS NOT LONGER CAPTURING. THAT PATIENT HAD TO BE BROUGHT BACK TO OUR LAB AND WE WE'RE STILL UNABLE TO SECURE THE WIRE IN PLACE. LUCKILY OUR EP PHYSICIAN WAS FREE TO PLACE A PERMANENT PACEMAKER AT THIS TIME, BUT THIS COULD HAVE EASILY BEEN A MAJOR PROBLEM HAD THE PATIENT NOT HAD A DECENT UNDERLYING RATE. "

  Patient problems: Insufficient Information

  MAUDE report 24415632 ↗
• MalfunctionDec 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "SIDE INFUSION PART WON'T GIVE BLOOD RETURN. IT SUCKS IN LARGE AMOUNTS OF AIR FORM THE SITE OF THE PACEMAKER WIRE ". ADDITIONAL INFORMATION STATES THAT ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 23742075 ↗
• MalfunctionMay 8, 2024Fluid/Blood Leak; Difficult to Open or Close; Fluid/Blood Leak; Difficult to Open or Close

  IT WAS REPORTED THAT "SOMETHING HAPPEN THAT CAUSED THE VALVE NOT TO CLOSE AFTER THE LOCKING AND CONTAMINATION SLEEVE WERE ATTACHED. THE SHEATH WAS BLEEDING BACK INTO THE SLEEVE AND STAFF NEEDED TO CHANGE OUT THE WHOLE SYSTEM. UPON REMOVING THE SHEATH THEY DID NOT NOTICE ANY DAMAGE OR LEAKS".

  Patient problems: Insufficient Information

  MAUDE report 19271892 ↗
• MalfunctionNov 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORT STATES, "BLOOD RETURN FROM TEMP WIRE AREA WITHIN THE SWANDOM AND BLOOD WITHIN THE SHEATH. I FOLLOWED UP WITH CC TEAM AND MENTIONED PATIENT WAS SHIPPED TO BI BOSTON FOR FURTHER EP TESTING WITH TEMP WIRE IN PLACE. I WAS TOLD DR DID SEE PATIENT OVER THE WEEKEND, BLEEDING WAS MAINTAINED. TEMP WIRE INDICATION- BRADYCARDIA, SYNCOPE".

  Patient problems: Insufficient Information

  MAUDE report 18133665 ↗
• MalfunctionOct 25, 2023Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT WHILE IN USE, THE PACER WIRE IS NOT CONDUCTING. AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 18003910 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K945229. One submission often covers many models, so check the product and lot details in each record.

• Z-3197-2018 · Jul 30, 2018 · Terminated
  ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in elec