ARROW IPN033460Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902095619), received between Apr 8, 2024 and Nov 15, 2024 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Material Separation; Material Separation

  IT WAS REPORTED "CALLED BY CPA FROM NORTHERN HOSPITAL ABOUT PICC "FRACTURE" HUB HAS FALLEN OFF THE PICC WHILST IN PATIENT ON WARD." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694559 ↗
• MalfunctionApr 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "RADIOLOGIST INSERTED PICC IN RIGHT UPPER ARM BASILIC VEIN UNDER IMAGING WITH NO PROBLEMS. THE PEEL-AWAY SHEATH TABS WERE GRASPED AND THE SHEATH PULLED APART 1CM. AT THE 1CM POINT THE TAB AND THE 1CM OF SHEATH TORE OFF COMPLETELY ON ONE SIDE, LEAVING THE OTHER TAB INTACT. SO ONE TAB AND 1CM OF SHEATH TORE OFF. THE INSERTER HAD TO USE A SCALPEL TO MAKE SMALL "NICKS" INTO REMAINING PART OF SHEATH TO REMOVE AND PEEL AWAY THE PEEL-AWAY SHEATH. THE SHEATH WAS SUCCESSFULLY REMOVED AND DID NOT APPEAR TO BE PUNCTURED AND REMAINED IN THE PATIENT. THE CONCERN WAS THAT THE SCALPEL MAY PUNCTURE THE PICC BUT IT WAS FELT THIS WAS THE ONLY WAY TO SAFELY REMOVE THE SHEATH WITHOUT PART OF THE PEEL-AWAY SHEATH TEARING OR SLIPPING OFF AND GOING INTO THE VESSEL." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 19058110 ↗

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