ARROW IPN033472Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902095657), received between Aug 30, 2024 and Jul 31, 2025 — classified as 6 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K080604); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJul 31, 2025Material Separation; Material Separation

  IT WAS REPORTED "PINK LUMEN OF PICC LINE SNAPED FROM PATIENT FORCE. THE PINK LUMEN HAD NO CLAP WHEN IT SNAPPED, SHE TOOK ONE OF THE CLAMPS FROM ANOTHER LUMEN TO CLAMP IT, END OF LUMEN ALSO COVERED WITH TEGADERM. 7F EDUCATOR DISCUSSED WITH VA NURSE PRACTITIONER KATIE, REQUESTED PICC TO BE REMOVED. PICC LINE IS REMOVED UNDER ASEPTIC TECHNIQUE AND PROTOCOL, PATIENT VITAL SIGNS ARE BETWEEN THE FLAGS, NO SIGNS OF INFECTION AT THE INSERTION SITE." A PIV WAS INSERTED TO CONTINUE THE TREATMENTS. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675579 ↗
• MalfunctionJan 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PICC PEEL-AWAY SHEATH RIPPED DURING INSERTION OF DILATOR. THE DEVICE WAS REMOVED IN ITS ENTIRETY AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179360 ↗
• MalfunctionOct 16, 2024Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED "THE INTRODUCER SHEATH IS MEANT TO SPLIT CLEANLY AS PART OF THE REMOVAL PROCESS AFTER THE LINE IS INSERTED. INSTEAD THE SHEATH TORE PARTIALLY AND THEN ONE OF THE HANDLES SNAPPED OFF." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, HOWEVER FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20460370 ↗
• MalfunctionSep 5, 2024Crack; Material Rupture; Crack; Material Rupture

  IT WAS REPORTED THAT: "EXTRAVASATION NOTED TO PT R) ARM WITH ++ SWELLING TO ARM AND R) HAND. TPN FLUID NOTED UNDER DRESSING. ALL INFUSIONS (HEPARIN + TPN) STOPPED AND PICC REMOVED. ON REMOVAL OF PICC LINE, PICC NOTED TO HAVE SMALL HAIRLINE FRACTURE DISTALLY ON PICC. VISIBLE SPLIT TO TUBING JUST PROXIMAL TO SKIN LEVEL. TPN AND HEPARIN INFUSIONS WERE STOPPED UNTIL NEW PICC LINE INSERTED. THE DEVICE WAS REMOVED IN ITS ENTIRETY AND PICC WAS REPLACED." THE RETURNED DEVICE PROVED TO BE RUPTURED. THERAPY WAS DELAYED BUT THE PATIENT WAS REPORTED AS FINE POST THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143737 ↗
• MalfunctionAug 30, 2024Material Separation; Material Separation

  IT WAS REPORTED: "PICC INSERTED THROUGH SHEATH AND WHEN THEY CRACKED PEEL AWAY SHEATH TO PULL IT APART, THE WHITE PLASTIC PART AT THE END BROKE OFF. SHEATH WAS ABLE TO BE REMOVED AND PICC REMAINED INSITU. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20105258 ↗
• MalfunctionAug 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "PICC INSERTED THROUGH SHEATH AND WHEN THEY CRACKED PEEL AWAY SHEATH TO PULL IT APART, THE WHITE PLASTIC PART AT THE END BROKE OFF. SHEATH WAS ABLE TO BE REMOVED AND PICC REMAINED INSITU. THERE WAS NO PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20105225 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080604. One submission often covers many models, so check the product and lot details in each record.

• Z-2024-2018 · Apr 11, 2018 · Terminated
  ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM