Xcela 55718Recalls & reported problems

Navilyst Medical, Inc. · Xcela PICC with PASV Valve Technology - 5Fx55cm Catheter IR-145 Kit · Class 2 · Implant

Data updated Oct 13, 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 H965557180), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 malfunction.

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

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Fracture1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

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

MalfunctionApr 17, 2025Fracture; Fracture
ADDITIONAL INFORMATION: A SPECTRUM TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM AN. ATO XCELA PASV 5F SL 55CM IR-145 KIT. THE LINE WAS INSERTED IN (B)(6) 2023, UNEVENTFUL, NO ISSUE. LINE CARE (FLUSHING, DRESSING) UNTIL DAY OF INCIDENT ((B)(6) 2025) AS PER INSTITUTION PROTOCOL, UNEVENTFUL, NO ISSUE. ON (B)(6) 2025, A NEW NEUTRON CONNECTOR WAS APPLIED, AND THERE WAS NO ISSUE. ON (B)(6) 2025, PRIOR TO COMMENCING CHEMOTHERAPY: GOOD BACKFLOW, NIL RESISTANCE TO FLUSHING WAS NOTED ON PICC LINE ASSESSMENT, NO ISSUE. A VISUAL ASSESSMENT OF THE PICC LINE WAS DOCUMENTED AS CLEAN, DRY, INTACT. ON (B)(6) 2025, THE NEUTRON CONNECTOR WAS DUE FOR CHANGE WITH PUMP REMOVAL AS PER PROTOCOL. THE NURSE WAS UNABLE TO REMOVE THE NEUTRON AFTER 2 ATTEMPTS. THIS WAS DONE IN A SEATED POSITION, WITH CONNECTOR TURNED IN AN ANTI-CLOCKWISE MANNER. THE NURSE ESCALATED IT TO A COLLEAGUE TO ASSIST, WHO WAS UNABLE TO REMOVE CONNECTOR BY HAND IN AN ANTI-CLOCKWISE MANNER. THE NURSE THEN USED A GAUZE TO WRAP AROUND THE NEUTRON TO FACILITATE ITS REMOVAL, WHICH SHE WAS ABLE TO ACCOMPLISH WITH EASE IN AN ANTI-CLOCKWISE FASHION. DURING THE REMOVAL PROCESS, NO SOUND OR ABNORMAL MOTION WAS NOT
Patient problems: Foreign Body In Patient
MAUDE report 21858352 ↗

Device details

UDI-DI	`H965557180`
Brand	Xcela
Model	55718
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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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