ARROW IPN032720Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902094568), received between Nov 20, 2023 and Nov 20, 2023 — classified as 1 malfunction.

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

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "DUAL-LUMEN PICC HAD TO BE REPLACED BECAUSE IT WAS LEAKING AT THE CONNECTION SITE NEXT TO THE WINGS WHERE THE STAT LOCK WOULD BE". AS A RESULT, THE PICC LINE WAS REPLACED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175349 ↗

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