ARROW IPN033458Recalls & reported problems

Teleflex Incorporated · ARROW(R) PICC Set · Class 2 · Implant

All models of ARROW (1494)

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

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902095602), received between Aug 28, 2024 and Oct 27, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 reports).

6 other recalls cover devices cleared under the same FDA submission (K113277); 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

Obstruction of Flow5
Material Separation1
Material Twisted/Bent1
Separation Problem1

Patient problems

Insufficient Information5
Foreign Body In Patient1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 27, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED "PICC BLOCKAGE". ALTEPASE WAS ADMINISTERED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 23393029 ↗
MalfunctionOct 27, 2025Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent
IT WAS REPORTED "PICC BLOCKAGE". ADDITIONAL INFORMATION RECEIVED STATES THE CATHETER WAS KINKED. ALTEPASE WAS ADMINISTERED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 23392993 ↗
MalfunctionOct 27, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED "PICC BLOCKAGE". ALTEPASE WAS ADMINISTERED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 23392784 ↗
MalfunctionOct 27, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED "PICC BLOCKAGE". ALTEPASE WAS ADMINISTERED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 23392676 ↗
MalfunctionOct 27, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED "PICC BLOCKAGE". ALTEPASE WAS ADMINISTERED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 23392635 ↗
InjuryAug 28, 2024Material Separation; Separation Problem; Material Separation; Separation Problem
IT WAS REPORTED THAT: "PICC WAS BEING INSERTED IN INTERVENTIONAL RADIOLOGY. PICC INSERTED THROUGH PEEL AWAY SHEATH HOWEVER WHEN THEY WERE PEELING SHEATH AWAY, IT BROKE AND LEFT PART OF IT INSIDE THE PATIENT'S ARM AND THEY COULD NOT ACCESS IT. AS THEY WERE IN IR, THEY ENDED UP GOING FEMORALLY AND REMOVING THE SHEATH AND THEN THE PICC. A NEW PICC WAS INSERTED WITHOUT INCIDENT. MEDICAL INTERVENTION: INSERTED CATHETER VIA FEMORAL VEIN TO APPROACH SHEATH TO HOOK IT AND REMOVE IT FROM VEIN. ANOTHER ATTEMPT AT THE PROCEDURE WAS SUCCESSFULLY COMPLETED."
Patient problems: Foreign Body In Patient
MAUDE report 20084105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113277. One submission often covers many models, so check the product and lot details in each record.

Z-2378-2026 · Apr 21, 2026 · Open, Classified
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR
Z-1254-2020 · Dec 20, 2019 · Terminated
PICC Set- PR-35052-HPHNM
Z-2023-2018 · Apr 11, 2018 · Terminated
ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM
Z-0602-2018 · Jul 25, 2017 · Terminated
ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
Z-0182-2018 · Jun 1, 2017 · Terminated
ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central
Z-0207-2016 · Oct 16, 2015 · Terminated
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS

Device details

UDI-DI	`00801902095602`
Brand	ARROW
Model	IPN033458
Catalog no.	PR-35552-HPHNL
Company	Teleflex Incorporated
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater than 30 days
Class	Class 2
FDA submission	K113277
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	Jul 16, 2021

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

A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

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All Catheter,intravascular,therapeutic,long-term greater 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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