ARROW IPN924165Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801902208696), received between Sep 21, 2023 and May 27, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (4 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: "THE DEVICE FEELS THICKER BUT FLIMSIER. IT SEEMS HARDER TO GET THROUGH PATIENT'S SKIN AND ALSO HAS ISSUES WITH IT BREAKING NOT CLEANLY OR NORMALLY." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE. ASSOCIATED COMPLAINTS: 9680794-2024-00500, 9680794-2024-00499, 9680794-2024-00498 AND 9680794-2024-00496.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399885 ↗
• MalfunctionMay 27, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: "THE DEVICE FEELS THICKER BUT FLIMSIER. IT SEEMS HARDER TO GET THROUGH PATIENT'S SKIN AND ALSO HAS ISSUES WITH IT BREAKING NOT CLEANLY OR NORMALLY." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE. ASSOCIATED COMPLAINTS: 9680794-2024-00500, 9680794-2024-00499, 9680794-2024-00498 AND 9680794-2024-00496.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399861 ↗
• MalfunctionMay 27, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: "THE DEVICE FEELS THICKER BUT FLIMSIER. IT SEEMS HARDER TO GET THROUGH PATIENT'S SKIN AND ALSO HAS ISSUES WITH IT BREAKING NOT CLEANLY OR NORMALLY." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE. ASSOCIATED COMPLAINTS: 9680794-2024-00500, 9680794-2024-00499, 9680794-2024-00498 AND 9680794-2024-00496.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399846 ↗
• MalfunctionMay 27, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: "THE DEVICE FEELS THICKER BUT FLIMSIER. IT SEEMS HARDER TO GET THROUGH PATIENT'S SKIN AND ALSO HAS ISSUES WITH IT BREAKING NOT CLEANLY OR NORMALLY." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE. ASSOCIATED COMPLAINTS: 9680794-2024-00500, 9680794-2024-00499, 9680794-2024-00498 AND 9680794-2024-00496.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399838 ↗
• MalfunctionMay 24, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT "WHEN TRYING TO THREAD SHEATH INTRODUCER IT WAS GETTING CAUGHT UP IN THE PATIENT'S SKIN AT THE POINT OF TRANSITION FROM DILATOR TO SHEATH. THAT TRANSITION FELT THICKER AND STICKIER THAN USUAL. IT STARTED TO MUSHROOM AND SPLIT. HAD TO PULL A NEW SHEATH INTRODUCER FROM ANOTHER KIT TO COMPLETE THE INSERTION". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391254 ↗
• MalfunctionMay 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "AFTER THE SHEATH WAS INSERTED AND THE PICC WAS THREADED, THE INSERTER TRIED TO SEPARATE THE TABS AND ONE SEPARATED. THE NURSE WAS ABLE TO FINISH PEELING THE TWO SIDES OF THE SHEATH APART AND COMPLETE THE CASE". THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339312 ↗
• MalfunctionMay 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE INTRODUCER CRACKED WHEN TRYING TO BREAK APART AND PULL THE DILATOR OUT. THEY WERE ABLE TO SPLIT THE DILATOR BY PLACING PRESSURE ON THE PICC AND SLOWLY PULLING ON THE REMAINING WING." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339255 ↗
• MalfunctionNov 6, 2023Fluid/Blood Leak; Obstruction of Flow; Material Split, Cut or Torn; Fluid/Blood Leak; Obstruction of Flow; Material Split, Cut or Torn

  IT WAS REPORTED THAT: THE PICC WAS FUNCTIONING WELL FOR 20 DAYS AT HOME. ON MONDAY 10/9, AT APPROXIMATELY 12PM, THE HOME CARE NURSE CHANGED THE DRESSING AND DREW LABS FROM THE PICC. THE PATIENT'S WIFE REPORTED THAT SHE HAD A HARD TIME FLUSHING THE PICC AT 5:30PM AND WAS UNABLE TO ADMINISTER HIS 5:30PM MEDS. HOME CARE CAME BACK OUT ON 10/10 AND SAID THE PICC WAS LEAKING AND HAD A PINHOLE IN IT. ON ASSESSMENT IN THE ED TODAY AT 2PM, THE PICC WAS COMPLETELY OCCLUDED AND THERE WAS LEAKING THROUGH A PINHOLE AT THE 2. 5CM MARK OF PICC CATHETER. VAT NURSE REMOVED THE PICC, AND VAT PLACED THE PICC IN A BIOHAZARD BAG AND FORCEFULLY FLUSHED THE PICC. A LARGE CLOT CAME OUT OF THE PICC AND VISIBLE SMALL LEAK AT THE 2.5CM MARK OF CATHETER. A NEW LINE WAS INSERTED IN THE OPPOSITE ARM. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072274 ↗
• MalfunctionSep 21, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THE PACKAGE WAS OPEN AT THE TOP LEFT CORNER UPON REMOVING FROM THE CASE. THE KIT WAS NO LONGER STERILE. NO PATIENT I NVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17794901 ↗