Vistec 4334Recalls & reported problems
Cardinal Health, Inc. · X-Ray Detectable Sponges,32 Ply · Class 1
All models of Vistec (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884527016686), received between Oct 1, 2019 and Mar 20, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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.
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping2
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED THAT THERE WAS ONE BUNDLED GAUZE THAT HAD 11 EACH BANDED TOGETHER INSTEAD OF 10 EACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16572719 ↗MalfunctionDec 16, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED THAT THE ITEM CAME WITH 11 GAUZE INSTEAD OF TEN IN A PACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9477514 ↗MalfunctionOct 1, 2019Packaging Problem; Packaging Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A PACK WITH 11 GAUZE INSTEAD OF 10.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9139961 ↗
Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices
- Vistec 7317Cardinal Health, Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall80 reports
- Situate G0804-12P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE120 reports
- Situate G0404-16P01CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE114 reports
- Situate G0804-16P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 recalls1 report
- Situate L1818-04P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall20 reports
- Situate G0404-16P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE60 reports
- AMD-RITMED 85995CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
- Medical Action Industries 403Medical Action Industries Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
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.
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