CentroVena One 1K0R7316Recalls & reported problems

Bard Access Systems, Inc. · CentroVena One™ Insertion System Central Venous Catheter · Class 2

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741231308), received between Aug 3, 2026 and Aug 4, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 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.

Reports received per month

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

Most reported problems

Device problems

Difficult or Delayed Separation2
Material Deformation1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 4, 2026Difficult or Delayed Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129742 ↗
MalfunctionAug 3, 2026Material Deformation; Difficult or Delayed Separation
It was reported by the customer that sheath tear was noticed on the device after the safety activation was slightly activated, then un-safety-ed again. It is unknown if the tear is a result of that, as it is a known feature that the blade in CentroVena one will start cutting the sheath as soon as you begin to pull the needle out even slightly. Not used on a patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116868 ↗

Device details

UDI-DI	`00801741231308`
Brand	CentroVena One
Model	1K0R7316
Company	Bard Access Systems, Inc.
Product code	SEF · Central venous catheter with manual insertion system
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Feb 2, 2026

Device type (GMDN): Central venous catheterization kit, short-term

A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Other Central venous catheter with manual insertion system devices

CentroVena One 1MC0R7320
Bard Access Systems, Inc. · Central venous catheter with manual insertion system
6 reports

All Central venous catheter with manual insertion system 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.

How reports and recalls are matched · Editorial policy · Report an error on this page