ARROW IPN924170Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902208740), received between Sep 30, 2024 and Sep 29, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933400 ↗
• MalfunctionSep 21, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842664 ↗
• MalfunctionMar 9, 2026Material Separation

  IT WAS REPORTED THAT "WHITE HUB CAME OFF PICC". 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 24545946 ↗
• MalfunctionJun 9, 2025Material Separation; Material Separation

  IT WAS REPORTED "PICC WAS PLACED ON 4/8 AND INCIDENT OCCURRED ON 5/15. THE BLUE EXTENSION LINE HUB SEPARATED FROM THE EXTENSION LINE WHERE THEY MEET, DUE TO A FRACTURE IN THE TUBING. IT APPEARS THERE IS STILL A SMALL SECTION OF TUBING INSIDE THE HUB. IT WAS REPORTED THAT THE LINE HAD BECOME CAUGHT UNDER THE BED RAIL WHILE STAFF WAS MOVING THE PATIENT. THE NURSE WHO WAS PRESENT REPORTED THAT IT WAS NOT A FORCEFUL PULL ON THE LINE BUT THERE WAS NO ONE ELSE THERE TO CONFIRM THIS AS THE VASCULAR ACCESS TEAM WAS NOT PRESENT AT THE TIME THE DAMAGE OCCURRED. THE PICC WAS REPLACED WITH AN OVER-THE-WIRE TECHNIQUE." 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 22165999 ↗
• MalfunctionMay 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED "ONE OF THE LUMENS RUPTURED WHILE BEING USED IN CT BETWEEN THE ZERO MARK AND THE HUB." THE LINE WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED STATES "THE PATIENT WAS BLEEDING BUT IM NOT SURE WHAT THE EXTENT OF THE DAMAGE WAS". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22095378 ↗
• MalfunctionSep 30, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT: "DURING THE CASE, THE NURSE ATTEMPTED TO INSERT THE GLIDETHRU SHEATH OVER DILATOR OVER THE GUIDEWIRE. WHEN THE PEEL-AWAY PORTION REACHED THE PATIENTS SKIN, SHE WAS UNABLE TO ADVANCE AND THE PEEL-AWAY PORTION BEGAN TO "TURTLENECK". ANOTHER KIT WAS OPENED AND A NEW SHEATH WAS USED WITH NO ISSUES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333249 ↗