Vistec 7320 (UDI 00884527017235)Recalls & reported problems

Cardinal Health, Inc. · X-Ray Detectable Sponges,32 Ply · Class 1

Data updated Oct 13, 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 00884527017235), received between Sep 12, 2016 and Sep 12, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

Most reported problems

Device problems

Loose or Intermittent Connection1
Material Integrity Problem1

Patient problems

No Known Impact Or Consequence To Patient2

Recent adverse event reports

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

MalfunctionSep 12, 2016Loose or Intermittent Connection
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE PAD. THE CUSTOMER REPORTS THE SPONGES CONTAIN LOOSE FIBERS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5943439 ↗
MalfunctionSep 12, 2016Material Integrity Problem
T WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE PAD. THE CUSTOMER REPORTS THE SPONGES CONTAIN LOOSE FIBERS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5943429 ↗

Device details

UDI-DI	`00884527017235`
Brand	Vistec
Model	7320
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	Yes
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 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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