ARROW IPN924171Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801902208757), received between Jun 2, 2024 and Aug 5, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2394-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionAug 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "THE PICC WAS NOT ADVANCING DUE TO RESISTANCE. THE INSERTER WHO WAS PLACING THE PICC WAS DELIBERATE IN WORKING WITH THE STYLET, BUT AFTER 2 ATTEMPTS TO PULL BACK THE STYLET BY ~ 1CM, SHE MET WITH NO MOVEMENT OF THE STYLET. SHE COULD NOT PULL OUT THE CATHETER OR THE STYLET INITIALLY. AFTER WARMING UP THE VESSEL BY APPLYING HEAT TO THE INSERTION TRACK, SHE CAREFULLY PULLED BACK THE CATHETER AND STYLET. WHEN THE CATHETER AND STYLET WERE OUT OF THE PATIENT THE INSERTER AND THE RESOURCE NURSE SAW THAT THE STYLET HAD PUNCTURED A HOLE IN THE CATHETER AT ~THE 27.5 CM MARK AND THE STYLET WAS HOOKED AT THE TIP OF THE CATHETER. WHEN WE PULLED THE STYLET OUT TO MEASURE AND ASSESS THAT THE NAVICURE TIP WAS INTACT, THEY COULD FEEL AND VISIBLY SEE THAT THERE WERE SHARP BARBS (APPROXIMATELY 5) NEAR THE DISTAL TIP OF THE STYLET." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00658 AND 9680794-2025-00659.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716048 ↗
• MalfunctionAug 5, 2025Physical Resistance/Sticking; Sharp Edges; Physical Resistance/Sticking; Sharp Edges

  IT WAS REPORTED "THE PICC WAS NOT ADVANCING DUE TO RESISTANCE. THE INSERTER WHO WAS PLACING THE PICC WAS DELIBERATE IN WORKING WITH THE STYLET, BUT AFTER 2 ATTEMPTS TO PULL BACK THE STYLET BY ~ 1CM, SHE MET WITH NO MOVEMENT OF THE STYLET. SHE COULD NOT PULL OUT THE CATHETER OR THE STYLET INITIALLY. AFTER WARMING UP THE VESSEL BY APPLYING HEAT TO THE INSERTION TRACK, SHE CAREFULLY PULLED BACK THE CATHETER AND STYLET. WHEN THE CATHETER AND STYLET WERE OUT OF THE PATIENT THE INSERTER AND THE RESOURCE NURSE SAW THAT THE STYLET HAD PUNCTURED A HOLE IN THE CATHETER AT ~THE 27.5 CM MARK AND THE STYLET WAS HOOKED AT THE TIP OF THE CATHETER. WHEN WE PULLED THE STYLET OUT TO MEASURE AND ASSESS THAT THE NAVICURE TIP WAS INTACT, THEY COULD FEEL AND VISIBLY SEE THAT THERE WERE SHARP BARBS (APPROXIMATELY 5) NEAR THE DISTAL TIP OF THE STYLET." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00658 AND 9680794-2025-00659.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715902 ↗
• MalfunctionJun 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "PICC WAS PLACED 5/16. ON 5/24, MALFUNCTION WAS SUSPECTED AND A CXR WAS PERFORMED. THE LINE WAS OBSERVED TO HAVE AN INTERNAL KINK 5.8 CM FROM THE INSERTION SITE. ADDITIONALLY, THE CATHETER WAS OBSERVED TO HAVE "BUCKLED" UNDER THE DRESSING, BUT AFTER A 1 CM MANIPULATION THE ISSUE APPEARED TO RESOLVE." THE LINE WAS SUCCCESSFULLY 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 22341491 ↗
• InjuryOct 23, 2024Material Separation; Material Separation

  IT WAS REPORTED "WE USED THIS KIT TO PLACE A PICC LINE FOR ONE OF OUR PATIENTS. EVERYTHING WITH PLACING THE PICC WAS GREAT, NO ISSUES AT ALL UNTIL THE REMOVAL OF THE DILATOR. WHEN GOING TO SNAP AND SEPARATE THE DILATOR, THE CANNULA ACTUALLY DETACHED FROM THE WINGS AND THEREFORE BECAME LODGED INTO THE PATIENTS VASCULATURE. I DID WHAT I COULD TO TRY TO RECOVER IT AT BEDSIDE, BUT ULTIMATELY WE DID HAVE TO TRANSFER THE PATIENT OVER TO (B)(6). UNDER FLUOROSCOPY, IR WAS ABLE TO RECOVER THE SHEATH AND IT WAS NOTED THAT IT LOOKED LIKE A COFFEE STRAW. IT HAD NOT SEPARATED AS IT WAS SUPPOSED TO." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Foreign Body In Patient

  MAUDE report 20514356 ↗
• MalfunctionJun 6, 2024Material Separation; Material Separation

  IT WAS REPORTED "PEEL AWAY SHEATH IS FACTURING AT THE WHITE WINGS WERE YOU PEEL IT. ONE WING IS CONSISTENTLY FALLING OFF THUS CREATING A RISK TO PATIENTS." 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 19475959 ↗
• MalfunctionJun 6, 2024Material Separation; Material Separation

  IT WAS REPORTED "PEEL AWAY SHEATH IS FACTURING AT THE WHITE WINGS WERE YOU PEEL IT. ONE WING IS CONSISTENTLY FALLING OFF THUS CREATING A RISK TO PATIENTS." 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 19475881 ↗
• MalfunctionJun 6, 2024Material Separation; Material Separation

  IT WAS REPORTED "PEEL AWAY SHEATH IS FACTURING AT THE WHITE WINGS WERE YOU PEEL IT. ONE WING IS CONSISTENTLY FALLING OFF THUS CREATING A RISK TO PATIENTS." 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 19475834 ↗
• MalfunctionJun 6, 2024Material Separation; Material Separation

  IT WAS REPORTED "PEEL AWAY SHEATH IS FACTURING AT THE WHITE WINGS WERE YOU PEEL IT. ONE WING IS CONSISTENTLY FALLING OFF THUS CREATING A RISK TO PATIENTS." 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 19475784 ↗
• MalfunctionJun 2, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "PEEL AWAY SHEATH BROKE WHEN PEELING". THE SHEATH WAS REMOVED. 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 19444879 ↗