ARROW IPN036540Recalls & reported problems

Teleflex Incorporated · Small Vein Arrowg+ard Blue(R) Two-Lumen CVC · Class 2

All models of ARROW (1494)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20801902116974), received between Jun 2, 2024 and Jun 2, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

11 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.

Recalls naming this device

Apr 21, 2026Open, Classified
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2376-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

Material Twisted/Bent1
Unintended Movement1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 2, 2024Material Twisted/Bent; Unintended Movement; Material Twisted/Bent; Unintended Movement
IT WAS REPORTED "WHILE PLACING THE ACTUAL CVC LINE (AFTER INITIAL PLACEMENT OF GUIDEWIRE, SKIN NICK, DIALATOR INSERTION, CONFIRMING GUIDEWIRE FREE AND MOBILE, ETC.) THE GUIDEWIRE KINKED AND MIGRATED OUT OF RIJ VESSEL. THIS NECESSITATED NEW ATTEMPT FOR PLACEMENT OF LINE (USING A DIFFERENT GUIDEWIRE FROM A COOK CATHETER KIT). ADDITIONAL INFORMATION FROM THE CUSTOMER WAS REQUESTED, NO INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 19444821 ↗

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-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	`20801902116974`
Brand	ARROW
Model	IPN036540
Catalog no.	CDC-25402-X1A
Company	Teleflex Incorporated
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	K900263
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 17, 2022

Device type (GMDN): Central venous catheterization kit, short-term

A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

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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 · each recall links to the FDA recall notice
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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