ARROW IPN033506Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902095715), received between Apr 8, 2024 and Dec 19, 2024 — classified as 3 malfunctions.

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

11 other recalls cover devices cleared under the same FDA submission (K112896); 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.

• MalfunctionDec 19, 2024Material Separation; Material Separation

  IT WAS REPORTED 'THE PATIENT HAS A UNILUMEN PICC LINE IN THE RIGHT UPPER LIMB FOR THE ADMINISTRATION OF TREATMENT. DURING THE DISINFECTION OF THE CATHETER PORT, THE PORT BROKE, AND THE BLUE SAFETY CLAMP DETACHED, THE REST OF THE CATHETER REMAINED INTACT, ALLOWING THE VENOCLYSIS EQUIPMENT TO BE CONNECTED, AND THERAPY WAS SUBSEQUENTLY STARTED'. THE PATIENT WAS FINE AND HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20976129 ↗
• MalfunctionSep 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: " A REPORT IS RECEIVED FROM ONCOLOGY INDICATING THAT THE CLAMP SPLIT AND DETACHED, LEAVING THE PATIENT WITH PICC INSERTED, BUT WITHOUT A SAFETY KEY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332820 ↗
• MalfunctionApr 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "DURING THE INSERTION OF THE PICC, AT THE MOMENT OF ADVANCING THE DILATOR AND INTRODUCER AND EVEN THOUGH NO FORCE WAS APPLIED, THE PEELABLE INTRODUCER OPENS AT THE TIP AND THE USE OF ANOTHER CATHETER IS NECESSARY." 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 19059555 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112896. 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-1820-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
• Z-1819-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code: PR 45541 HPHNL
• Z-1811-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
• Z-1822-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45552 HPHNM
• Z-1327-2018 · Dec 22, 2017 · Terminated
  Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
• Z-0996-2018 · Nov 27, 2017 · Terminated
  Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow CVC is indicated to provide short-ter
• Z-2698-2017 · Jun 12, 2017 · Terminated
  Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
• Z-2331-2017 · May 9, 2017 · Terminated
  1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for
• Z-1705-2017 · Mar 3, 2017 · Terminated
  The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
• 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