ARROW IPN033362 (REF PR-05052-HP)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902095381), received between Jan 28, 2021 and Jan 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJan 28, 2021Break; Break

  THE COMPLAINT IS REPORTED AS: "THE PROBLEM HAPPENED WHEN THE NURSE TRIED TO INTRODUCE THE PICC THROUGH THE INSERTION SHEATH, HE TRIED THREE TIMES WITHOUT SUCCESS, IT GOT STOCK THE THREE TIMES, AND THEN HE WITHDREW ALL THE PARTS AND CHECKED THE DEVICE ENTIRELY AND REALIZED THAT THE PEEL AWAY WAS BROKEN IN THE MIDDLE." NO PATIENT HARM WAS REPORTED. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11246121 ↗

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-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
• 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-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