ARROW IPN032935Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features · Class 2 · Implant

All models of ARROW (1494)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902069528), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

54 other recalls cover devices cleared under the same FDA submission (K071538); 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

Device problems

Biocompatibility1

Patient problems

Anaphylactic Shock1

Recent adverse event reports

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

InjuryJul 25, 2023Biocompatibility; Biocompatibility
IT WAS REPORTED THE PATIENT EXPERIENCED AN ANAPHYLAXIS RESPONSE TO THE CHLORHEXIDINE IN THE CATHETER. THE CATHETER WAS REMOVED, CASE WAS CANCELED, AND PATIENT MOVED TO THE ICU. THE PATIENT HAD A FULL RECOVERY WITHIN 24 HOURS. POST REMOVAL OF CATHETER, THE PATIENT TESTED POSITIVE/SENSITIVE TO CHG. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "FINE". NO INFORMATION WAS AVAILABLE REGARDING THE SYMPTOMS THE PATIENT EXPERIENCED OR THE TREATMENT RECEIVED.
Patient problems: Anaphylactic Shock
MAUDE report 17388444 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071538. 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-1914-2026 · Mar 11, 2026 · Open, Classified
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-4
Z-2123-2026 · Jan 7, 2026 · Open, Classified
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Z-0002-2024 · Aug 10, 2023 · Open, Classified
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024 · Aug 10, 2023 · Open, Classified
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0352-2023 · Oct 27, 2022 · Terminated
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-
Z-0351-2023 · Oct 27, 2022 · Terminated
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
Z-1604-2022 · May 25, 2022 · Open, Classified
TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
Z-1998-2018 · 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 Code: ASK-427
Z-1995-2018 · Apr 11, 2018 · Terminated
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product
Z-1994-2018 · Apr 11, 2018 · Terminated
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
Z-1992-2018 · Apr 11, 2018 · Terminated
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
Z-1989-2018 · Apr 11, 2018 · Terminated
ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
Z-1990-2018 · Apr 11, 2018 · Terminated
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
Z-2000-2018 · Apr 11, 2018 · Terminated
ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH

…and 39 more.

Device details

UDI-DI	`00801902069528`
Brand	ARROW
Model	IPN032935
Catalog no.	CA-45703-P1A
Company	Teleflex Incorporated
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	K071538
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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