ARROW IPN033430Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20801902095521), received between Jun 25, 2024 and Apr 23, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K113277); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED "GLIDE THRU SHEATH BROKEN HALFWAY WHILE REMOVING". 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 21889348 ↗
• MalfunctionJul 5, 2024Complete Blockage; Difficult to Advance; Complete Blockage; Difficult to Advance

  IT WAS REPORTED THAT: "NEW PICC WAS CHANGED TO THE PATIENT, BUT MY DOCTOR FOUND SOME DIFFICULTY DURING INSERTION. THE DISTAL PORT COULDN'T FLUSH OR WITHDRAW AFTER INSERTION AND LOCATED AT 1/3 OF SVC. THEY HAVE TRIED FEW TIMES TO RELOCATE AND FLUSH OR WITHDRAW BUT STILL FAIL. AT THE END DOCTOR REMOVED IT AND CUT THE TIP OF PICC THEN EVERYTHING GOES SMOOTHLY WITHOUT COMPLAINT." ASSOCIATED COMPLAINT 9680794-2024-00589.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678100 ↗
• MalfunctionJun 25, 2024Stretched; Stretched

  IT WAS REPORTED "PICC CATHETER WAS FOUND EXPANDED DURING NURSE'S ROUND". A NEW PICC LINE WAS USED AND THERAPY WAS CONTINUED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTD AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605826 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113277. 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-1254-2020 · Dec 20, 2019 · Terminated
  PICC Set- PR-35052-HPHNM
• Z-2023-2018 · Apr 11, 2018 · Terminated
  ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM
• Z-0602-2018 · Jul 25, 2017 · Terminated
  ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
• Z-0182-2018 · Jun 1, 2017 · Terminated
  ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central
• Z-0207-2016 · Oct 16, 2015 · Terminated
  ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS