ARROW IPN914919Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Plus(R) Three-Lumen CVC Kit · Class 2

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: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902159806), received between Aug 20, 2021 and Aug 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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

Contamination1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionAug 20, 2021Contamination; Contamination
THE USER WAS INSERTING AN EMERGENT CATHETER IN THE ICU. DURING INSERTION, JUST PRIOR TO PASSING THE WIRE, THE USER NOTICED A WELL-EM BEDDED HAIR WITHIN THE GUIDEWIRE AND "ACTED APPROPRIATELY". NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12350864 ↗

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-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-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-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-1991-2018 · Apr 11, 2018 · Terminated
Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM a
Z-1997-2018 · Apr 11, 2018 · Terminated
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH
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-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-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-2000-2018 · Apr 11, 2018 · Terminated
ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
Z-1988-2018 · Apr 11, 2018 · Terminated
Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

…and 39 more.

Device details

UDI-DI	`10801902159806`
Brand	ARROW
Model	IPN914919
Catalog no.	ASK-45703-PMMH
Company	Teleflex Incorporated
Product code	FOZ · Catheter, intravascular, therapeutic, short-term less than 30 days
Class	Class 2
FDA submission	K071538
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	Oct 11, 2023

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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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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