ARROW IPN914872Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902158915), received between Apr 25, 2022 and May 20, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K042126); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED "FRACTURE TO LUMEN UNDERNEATH WHITE HUB". A NEW PICC LINE WAS PLACED UNDER FLUOROSCOPY AND IT WAS REPORTED THERE WAS A MINOR INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 14455590 ↗
• MalfunctionApr 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS "FRACTURED LINE". THE CATHETER WAS INSERTED ON (B)(6) 2022. THE ISSUE WAS DETECTED BY THE NURSE WHEN TRYING TO ASPIRATE LINE FOR BLOOD SAMPLING. THE CATHETER WAS REMOVED AND REPLACED. UPON REMOVAL THE USER VISUALIZED SALINE LEAKING WHEN FLUSHED ON THE EXTENSION LINE WHERE IT CONNECTS TO THE WHITE HUB. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196664 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042126. One submission often covers many models, so check the product and lot details in each record.

• Z-2378-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR
• Z-2825-2015 · Aug 27, 2015 · Terminated
  Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
• 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-1503-2009 · Feb 11, 2009 · Terminated
  Arrow Peripherally Inserted Central Catheter