Xcela 25126Recalls & reported problems

Navilyst Medical, Inc. · Xcela PICC with PASV Valve Technology - 5F x 55cm Dual Lumen Catheter IR-145 Kit · Class 2 · Implant

All models of Xcela (39)

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 H965251260), received between Jun 27, 2016 and Jun 27, 2016 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Kinked” (3 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 18, 2026.

Most reported problems

Device problems

Kinked3
Occlusion Within Device3
Backflow1
Fracture1
Knotted1

Patient problems

No Known Impact Or Consequence To Patient4

Recent adverse event reports

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

MalfunctionJun 27, 2016Backflow; Backflow
PICC PLACED ON (B)(6) IN PATIENT'S RT CEPHALIC. IT WAS NOTICED THAT THE BLOOD WAS BACKING UP INTO THE ORANGE LUMEN OF THE PICC. THE PICC WAS REMOVED AND REPLACED WITH A CUFFED CVC.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5751887 ↗
MalfunctionJun 27, 2016Kinked; Occlusion Within Device; Kinked; Occlusion Within Device
PICC PLACED ON (B)(6). THE PATIENT HAD NO BLOOD RETURN AND WAS SENT TO (B)(4). IMAGING SHOWED THAT THE PICC WAS KINKED IN THE BASCILIC VESSEL. (B)(4) REMOVED THE PICC AND THEN PLACED ANOTHER PICC IN THE PATIENT'S RT CEPHALIC.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5751880 ↗
MalfunctionJun 27, 2016Kinked; Knotted; Occlusion Within Device; Kinked; Knotted; Occlusion Within Device
PICC PLACED ON (B)(6). ON (B)(6) THE PATIENT HAD NO BLOOD RETURN AND WAS SENT TO IR. IMAGING SHOWED THAT THE PICC WAS TIED IN A KNOT AND KINKED IN THE BASILIC VESSEL. IR THEN PLACED ANOTHER PICC IN THE OPPOSITE ARM BASILIC VEIN ON (B)(6).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5751868 ↗
MalfunctionJun 27, 2016Fracture; Kinked; Occlusion Within Device; Fracture; Kinked; Occlusion Within Device
PICC PLACED ON (B)(6). COULD NOT GET A BLOOD RETURN, SO PATIENT WAS BROUGHT TO IR. IMAGING SHOWED THAT THE CATHETER WAS KINKED IN THE BASILIC VESSEL AND HAD A HOLE 8CM DOWN ON THE PICC. THE DEVICE WAS REMOVED AND REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5751853 ↗

Device details

UDI-DI	`H965251260`
Brand	Xcela
Model	25126
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	In Commercial Distribution
Record updated	Jun 22, 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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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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