ARROW IPN924173Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902208771), received between Oct 17, 2024 and Jul 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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-2370-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC PLACED 5/15 WITH THE "0" MARK AT THE SKIN IN A PATIENT IN MEDICAL ICU. ON 6/15 OR 6/16, LEAKAGE WAS OBSERVED FROM THE INSERTION SITE. A SALINE FLUSH WAS GIVEN AND SIMULTANEOUS LEAKAGE OF SALINE WAS OBSERVED FROM INSERTION SITE. THIS WAS AGAIN OBSERVED AT THE 3 CM MARK WHEN FLUSHING AFTER PICC WAS REMOVED. PICC WAS REMOVED AND REPLACED WITH A NEW PICC. WE DO NOT KNOW THE MEDICATIONS INFUSED AT THIS TIME." 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 22436835 ↗
• MalfunctionOct 17, 2024Material Frayed; Material Separation; Material Split, Cut or Torn; Material Frayed; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED "INTRODUCER SPLIT AND WAS FRAYED." ADDITIONAL INFORMATION REPORTED "THE WHITE TABS FORM THE PEEL AWAY SHEATH BROKE DURING USE." THERE WAS NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471716 ↗