ARROW IPN037878Recalls & reported problems

Teleflex Incorporated · Arrowg+ard Blue Advance(TM) PICC pre-loaded with ARROW(R) TipTracker(TM) Stylet · 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: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902132889), received between Aug 18, 2021 and Aug 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K160925); 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

Deformation Due to Compressive Stress1

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 18, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
THE COMPLAINT IS REPORTED AS: THE DILATOR KINKED UPON INSERTION. THE SHEATH OVER THE DILATOR PART PUSHED BACK. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12339128 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160925. One submission often covers many models, so check the product and lot details in each record.

Z-0004-2024 · Aug 10, 2023 · Open, Classified
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, lo
Z-2383-2018 · May 17, 2018 · Terminated
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave c
Z-2384-2018 · May 17, 2018 · Terminated
VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wav
Z-2382-2018 · May 17, 2018 · Terminated
VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG
Z-2028-2018 · Apr 11, 2018 · Terminated
VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP
Z-2027-2018 · Apr 11, 2018 · Terminated
VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
Z-2026-2018 · Apr 11, 2018 · Terminated
VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ

Device details

UDI-DI	`30801902132889`
Brand	ARROW
Model	IPN037878
Catalog no.	CDC-45563-TTS
Company	Teleflex Incorporated
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater than 30 days
Class	Class 2
FDA submission	K160925
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	Jun 23, 2023

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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