ARROW IPN030135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902102249), received between Feb 9, 2024 and May 1, 2024 — classified as 2 malfunctions.

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

12 other recalls cover devices cleared under the same FDA submission (K900263); 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 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE GUIDE WIRE TO BE BENT. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219421 ↗
• MalfunctionFeb 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE GUIDE WIRE TO BE FAULTY. SO THE MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE." THE RETURNED DEVICE WAS FOUND TO BE KINKED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675477 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900263. One submission often covers many models, so check the product and lot details in each record.

• Z-2376-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-
• Z-0053-2020 · May 17, 2019 · Terminated
  Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous acces
• Z-2886-2018 · Jul 3, 2018 · Terminated
  Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous acc
• Z-1985-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
• Z-1984-2018 · Apr 11, 2018 · Terminated
  Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
• Z-1333-2018 · Dec 22, 2017 · Terminated
  ARROWg+ard Blue CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheter
• Z-1001-2018 · Nov 27, 2017 · Terminated
  ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or condi
• Z-2337-2017 · May 9, 2017 · Terminated
  ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
• Z-1830-2012 · May 3, 2012 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circ
• Z-2496-2010 · Jul 29, 2010 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
• Z-1499-2009 · Feb 11, 2009 · Terminated
  Arrow ARROWg+ard CVCs (Central Venous Catheters)
• Z-0082-04 · Sep 16, 2003 · Terminated
  Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm