ARROW IPN030195Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902102423), received between Nov 29, 2023 and Feb 11, 2026 — classified as 3 malfunctions.

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

22 other recalls cover devices cleared under the same FDA submission (K993691); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 11, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDEWIRE, WHICH WAS FACTORY-COILED IN A PLASTIC SHEATH, HAD A KINK LOCATED ON THE PROXIMAL PART, 5 CM BEFORE THE TIP." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "OKAY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314807 ↗
• MalfunctionFeb 15, 2024Migration; Migration

  IT WAS REPORTED "ACCIDENTAL REMOVAL OF THE CENTRAL VENOUS CATHETER DUE TO DEFECTIVE EQUIPMENT. THE ATTACHMENT POINTS OF THE CATHETER ARE INTACT AND PROPERLY ATTACHED TO THE SKIN. (FRAGILE PLASTIC OF THE FINS DOES NOT GUARANTEE THE SAFETY OF THE CATHETER ATTACHMENT". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710304 ↗
• MalfunctionNov 29, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT: DURING THE INSTALLATION OF THE DEVICE, WHEN TRYING TO REMOVE THE GUIDE WITH THE CATHETER ALREADY INSERTED, THE GUIDE PRESENTS RESISTANCE TO REMOVAL, SO THE COMPLETE REMOVAL OF THE CATHETER + GUIDE DEVICE IS CARRIED OUT. ONCE OUTSIDE, IT IS FOUND THAT THE GUIDE IS BENT.

  Patient problems: Insufficient Information

  MAUDE report 18226160 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993691. 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-1106-2021 · Jan 6, 2021 · Terminated
  Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703
• Z-0192-2020 · Jul 18, 2019 · Terminated
  Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: Th
• Z-0468-2019 · Sep 21, 2018 · Terminated
  Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter perm
• Z-0282-2019 · Aug 30, 2018 · Terminated
  Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases
• Z-2004-2018 · Apr 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-4
• Z-2002-2018 · Apr 11, 2018 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802
• Z-2003-2018 · Apr 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH
• Z-2005-2018 · Apr 11, 2018 · Terminated
  ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
• Z-2001-2018 · Apr 11, 2018 · Terminated
  Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
• Z-1335-2018 · Dec 22, 2017 · Terminated
  AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-
• Z-1152-2018 · Dec 21, 2017 · Terminated
  ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jug
• Z-0656-2018 · Oct 17, 2017 · Terminated
  ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
• Z-2332-2017 · May 9, 2017 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access
• Z-1507-2014 · Jul 17, 2013 · Terminated
  Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.

…and 7 more.