Vaxcel 45458Recalls & reported problems

Navilyst Medical, Inc. · Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter IR-145 Kit · Class 2 · Implant

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

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

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M001454580), received between Aug 25, 2016 and Aug 25, 2016 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

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

Fluid/Blood Leak6
Fracture6

Patient problems

No Known Impact Or Consequence To Patient6

Recent adverse event reports

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

MalfunctionAug 25, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
AS REPORTED BY HOSPITAL IN (B)(6), THE HUB OF A VALVED PICC CRACKED AND LEAKED DURING FLUSHING. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5904279 ↗
MalfunctionAug 25, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
AS REPORTED BY HOSPITAL IN (B)(6), THE HUB OF A VALVED PICC CRACKED AND LEAKED DURING FLUSHING. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5904220 ↗
MalfunctionAug 25, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
AS REPORTED BY HOSPITAL IN (B)(6), THE HUB OF A VALVED PICC CRACKED AND LEAKED DURING FLUSHING. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5904216 ↗
MalfunctionAug 25, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
AS REPORTED BY HOSPITAL IN (B)(6), THE HUB OF A VALVED PICC CRACKED AND LEAKED DURING FLUSHING. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5904207 ↗
MalfunctionAug 25, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
AS REPORTED BY HOSPITAL IN (B)(4), THE HUB OF A VALVED PICC CRACKED AND LEAKED DURING FLUSHING. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5904203 ↗
MalfunctionAug 25, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
AS REPORTED BY HOSPITAL IN (B)(6), THE HUB OF A VALVED PICC CRACKED AND LEAKED DURING FLUSHING. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5904197 ↗

Device details

UDI-DI	`M001454580`
Brand	Vaxcel
Model	45458
Company	Navilyst Medical, Inc.
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater than 30 days
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Feb 19, 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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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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