ARROW IPN927748Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902214895), received between Nov 16, 2023 and Oct 11, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THE PEEL AWAY BUCKLED IN THE MIDDLE OF THE SHEATH, IT WAS NOT A DIFFICULT INSERTION AND THE CLINICIAN IS VERY SKILLED AND FAMILIAR WITH "CHOKING UP" ON THE SHEATH AND ADVANCING IN SMALL INCREMENTS. THEY HAD TO REPLACE THE SHEATH WITH ANOTHER SINGLE STERILE BUT THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT." 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 20428283 ↗
• MalfunctionSep 26, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT: "PEEL AWAY DID NOT TEAR CORRECTLY, THE DISTAL TIP DID NOT SEPARATE, THE CLINICIAN HAD TO USE FORCEPS TO REMOVE DISTAL END OF SHEATH FROM THE BODY OF THE PICC DURING THE INSERTION. THEY WERE ABLE TO REMOVE THE PEEL AWAY AND COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THIS WAS THE 3RD INCIDENT RELATED TO THIS SAME INCOMPLETE TEARING ISSUE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINTS: 9680794-2024-01004, AND 9680794-2024-01003.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309044 ↗
• MalfunctionFeb 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "NURSE WAS ATTEMPTING TO ADVANCE THE PEEL-AWAY INTO A YOUNG PATIENT WITH TOUGH SKIN AND THE PEEL-AWAY ACCORDIONED ABOUT 1 CM BELOW THE PROXIMAL END. THE SHEATH WAS REPLACED WITH A GAULT SHEATH AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT". NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658364 ↗
• MalfunctionNov 16, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT: WHEN THE PHYSICIAN WAS INSERTING THE PEEL AWAY SHEATH INTO THE UPPER ARM OF THE PATIENT, RESISTANCE WAS ENCOUNTERED. WHEN THE SHEATH WAS REMOVED IT WAS NOTED THAT THE TIP OF THE SHEATH WAS DEFORMED, AND THE BODY HAD CRUMPLED. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS REPORTED AS FINE POST THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147012 ↗