ARROW IPN914865Recalls & reported problems

Teleflex Incorporated · PICC Two-Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter · 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 10801902158403), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 injury.

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

4 other recalls cover devices cleared under the same FDA submission (K042126); 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

Material Rupture1

Patient problems

Extravasation1

Recent adverse event reports

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

InjuryJan 27, 2021Material Rupture; Material Rupture
THE COMPLAINT IS REPORTED AS: THE CATHETER HAD A "RUPTURE IN THE MIDDLE" AND "FLUID LEAKED INTO NON-INTRAVASCULAR SPACES CAUSING PHLEBITIS" IN THE PATIENT'S UPPER LIMB. THE CATHETER WAS REMOVED AND REPLACED IMMEDIATELY. IT WAS UNKNOWN IF THE PATIENT RECEIVED TREATMENT FOR THE "PHLEBITIS". THE PATIENT'S CONDITION WAS REPORTED AS "IN OPTIMAL HEALTH".
Patient problems: Extravasation
MAUDE report 11236396 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042126. 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-2825-2015 · Aug 27, 2015 · Terminated
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Z-2462-2015 · Jul 30, 2015 · Terminated
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
Z-1503-2009 · Feb 11, 2009 · Terminated
Arrow Peripherally Inserted Central Catheter

Device details

UDI-DI	`10801902158403`
Brand	ARROW
Model	IPN914865
Catalog no.	PS-01652
Company	Teleflex Incorporated
Product code	LJS · Catheter, intravascular, therapeutic, long-term greater than 30 days
Class	Class 2
FDA submission	K042126
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	Dec 3, 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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