ARROW IPN037307Recalls & reported problems

Teleflex Incorporated · Arrowg+ard Blue Advance(TM) PICC pre-loaded with Arrow(R) VPS Precision(TM) Stylet · Class 2 · Implant

All models of ARROW (1494)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50801902120811), received between Jan 25, 2021 and Jan 8, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (K153487); 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Separation3
Material Deformation1

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 8, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE EXTENSION LUMEN HUB BROKE OFF DURING THE PROCESS OF TURNING A PATIENT. THE LINE WAS DISCONTINUED AND DID NOT REQUIRE REPLACEMENT. THE PICC WAS THEN REMOVED. THE PATIENT HAD NO HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21101185 ↗
MalfunctionSep 15, 2021Material Separation; Material Separation
CUSTOMER REPORTED "PORT SNAPPED OFF" WHILE PRONING A PATIENT. NO PATIENT HARM REPORTED. THE CATHETER WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12478837 ↗
MalfunctionMay 13, 2021Material Separation; Material Separation
CUSTOMER REPORTED THE HUB SNAPPED OFF OF THE PICC LINE. THE LINE HAD BEEN PLACED AND WAS IN USE FOR 3 DAYS PRIOR TO THE ISSUE. THE PICC LINE WAS REPLACED IN THE OPPOSITE ARM. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE AS A RESULT OF THIS ISSUE. THE NURSE NOTED WHITE MEDICATION LEFT IN THE LUMEN, EITHER DIPROVAN OR "PROPOFOL", WHEN REPLACING THE LINE. THE PATIENT WAS INTUBATED AND IN ICU. THE PATIENT'S CONDITION WAS REPORTED AS CRITICAL AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11823536 ↗
MalfunctionJan 25, 2021Material Deformation; Material Deformation
CUSTOMER REPORTS THE GLIDE THRU SHEATH WAS DAMAGED AS IT APPEARS IT WAS LIKE AN "ACCORDION", SO THE DILATOR BENT AND WOULD NOT ALLOW IT TO INSERT INTO THE PATIENT. THE PEEL AWAY SHEATH WAS BROKEN EARLY AND THE PROBLEM RESOLVED. NO PATIENT HARM REPORTED. THE PICC WAS SUCCESSFULLY PLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11228229 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153487. One submission often covers many models, so check the product and lot details in each record.

Z-0001-2024 · Aug 10, 2023 · Open, Classified
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Ter
Z-1810-2019 · Apr 23, 2019 · Terminated
Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2
Z-1807-2019 · Apr 23, 2019 · Terminated
Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44063 VPS2
Z-1808-2019 · Apr 23, 2019 · Terminated
Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45041 VPS2
Z-1365-2019 · Dec 13, 2018 · Terminated
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripher
Z-1366-2019 · Dec 13, 2018 · Terminated
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripher
Z-3199-2018 · Jul 17, 2018 · Terminated
4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
Z-3200-2018 · Jul 17, 2018 · Terminated
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2

Device details

UDI-DI	`50801902120811`
Brand	ARROW
Model	IPN037307
Catalog no.	CDC-45563-VPS2
Company	Teleflex Incorporated
Product code	LJS · Catheter, intravascular, therapeutic, long-term greater than 30 days
Class	Class 2
FDA submission	K153487
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 16, 2022

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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