Vistec 7114Recalls & reported problems

Cardinal Health, Inc. · X-Ray Detectable Sponges,16 Ply · Class 1

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 10884527016952), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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

Component Missing1

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.

MalfunctionNov 24, 2025Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THEY RECEIVED 9 INSTEAD OF 10 GAUZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639273 ↗

Device details

UDI-DI	`10884527016952`
Brand	Vistec
Model	7114
Company	Cardinal Health, Inc.
Product code	GDY · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 31, 2025

Device type (GMDN): Radiopaque woven surgical sponge

A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices

Vistec 7317
Cardinal Health, Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
1 recall80 reports
Situate G0804-12P02CN-1
Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
120 reports
Situate G0404-16P01CN-1
Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
114 reports
Situate G0804-16P02CN-1
Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
2 recalls1 report
Situate L1818-04P01C-1
Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
1 recall20 reports
Situate G0404-16P01C-1
Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
60 reports
AMD-RITMED 55992C
AMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
1 recall0 reports
AMD-RITMED 85995C
AMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
1 recall0 reports

All GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.