ARROW IPN030917Recalls & reported problems

Teleflex Incorporated · Multi-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter · Class 2 · Implant

All models of ARROW (1494)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902029338), received between Sep 30, 2024 and Sep 30, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Twisted/Bent4

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE PHYSICIAN, WHILE PREPARING THE CVC SET BEFORE INJECTING IT INTO THE PATIENT, DISCOVERED THAT THE WIRE IN THE PACKAGE WAS KINKED." ASSOCIATED COMPLAINTS: 3006425876-2024-00935, 3006425876-2024-00934, 3006425876-2024-00933 AND 3006425876-2024-00930.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20333058 ↗
MalfunctionSep 30, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE PHYSICIAN, WHILE PREPARING THE CVC SET BEFORE INJECTING IT INTO THE PATIENT, DISCOVERED THAT THE WIRE IN THE PACKAGE WAS KINKED." ASSOCIATED COMPLAINTS: 3006425876-2024-00935, 3006425876-2024-00934, 3006425876-2024-00933 AND 3006425876-2024-00930.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20333054 ↗
MalfunctionSep 30, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE PHYSICIAN, WHILE PREPARING THE CVC SET BEFORE INJECTING IT INTO THE PATIENT, DISCOVERED THAT THE WIRE IN THE PACKAGE WAS KINKED." ASSOCIATED COMPLAINTS: 3006425876-2024-00935, 3006425876-2024-00934, 3006425876-2024-00933 AND 3006425876-2024-00930.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20332960 ↗
MalfunctionSep 30, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE PHYSICIAN, WHILE PREPARING THE CVC SET BEFORE INJECTING IT INTO THE PATIENT, DISCOVERED THAT THE WIRE IN THE PACKAGE WAS KINKED." ASSOCIATED COMPALINTS: 3006425876-2024-00935, 3006425876-2024-00934, 3006425876-2024-00933 AND 3006425876-2024-00930.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20332959 ↗

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

Device details

UDI-DI	`10801902029338`
Brand	ARROW
Model	IPN030917
Catalog no.	CV-22703-E
Company	Teleflex Incorporated
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	K900263
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 19, 2021

Device type (GMDN): Centrally-inserted central venous catheter

A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.

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All Catheter,intravascular,therapeutic,short-term less than 30 days devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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