ARROW IPN033364Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50801902095393), received between Jun 14, 2021 and Nov 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K073451); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "DEFECTIVE PROXIMAL HUB (WHITE COLOR) LOOSE FROM THE LUMEN. " THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL I NTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 23542583 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT "DOCTOR CLAIMED THAT THE PROXIMAL PORT WAS BROKEN. THE EVENT OCCURRED DURING HIS OPERATION IN THE INTERVENTION ROOM. HE CHANGED TO A NEW PICC SET TO FINISH THE OPERATION." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 22335391 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT " WHEN DR. INSERTED PICC CATHETER LINE INTO PATIENT'S VESSEL, HE FOUND THAT THE HUB SLIPPED OUT FROM THE CATHETER. THEY SOLVED THE PROBLEM BY REMOVING THE DEFECTED ONE AND REPLACING WITH A NEW ONE. THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245851 ↗
• MalfunctionJun 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE NURSE FOUND THE CATHETER LEAKING AT THE JUNCTURE HUB FROM THE PROXIMAL PORT. CATHETER HAD BEEN INSERTED ON (B)(6) 2021. IT WAS R EPORTED THE DEVICE WAS REMOVED AND THE DOCTOR CHANGED THE CATHETER. THERE WAS A DELAY IN THERAPY WITHOUT HARM TO THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11993943 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073451. One submission often covers many models, so check the product and lot details in each record.

• Z-2590-2023 · Aug 10, 2023 · Open, Classified
  Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
• Z-0127-2016 · Sep 18, 2015 · Terminated
  4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
• Z-2489-2015 · Jul 30, 2015 · Terminated
  Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
• Z-0066-2015 · Aug 6, 2014 · Terminated
  Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
• Z-1682-2010 · Mar 29, 2010 · Terminated
  Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-0704