VistecRecalls & reported problems across all models
Cardinal Health, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 8 models of Vistec by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Sep 12, 2016 and Dec 26, 2025 — classified as 1 injury, 140 malfunctions.
The most frequently reported specific device problem is “Component Missing” (33 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Vistec recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 17, 2017Class IITerminated
Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.
Z-0534-2018 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported Vistec problems
Device problems
- Component Missing33
- Material Frayed24
- Material Separation22
- Material Fragmentation16
- Packaging Problem12
- Device Misassembled During Manufacturing /Shipping8
- Manufacturing, Packaging or Shipping Problem5
- Unraveled Material5
Patient problems
- No Clinical Signs, Symptoms or Conditions62
- No Consequences Or Impact To Patient34
- No Known Impact Or Consequence To Patient21
- No Patient Involvement15
- Insufficient Information4
- No Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
Vistec models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vistec 7317GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall80 reports
- Vistec 7148GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE27 reports
- Vistec 7318GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE17 reports
- Vistec 7462GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE9 reports
- Vistec 4334GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE3 reports
- Vistec 7320GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 reports
- Vistec 7463GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 reports
- Vistec 7114GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 report
Recent Vistec adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2025Component Missing; Component Missing
TH CUSTOMER REPORTED THAT EACH PACK CONTAINED ONLY 9 PIECES PER BUNDLE INSTEAD OF THE EXPECTED 10 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23896004 ↗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 ↗MalfunctionAug 7, 2025Component Missing; Component Missing
THE CUSTOMER REPORTED ONLY 9 IN THE TRAY INSTEAD OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22745545 ↗MalfunctionAug 26, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE ITEM WAS SHREDDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20065408 ↗MalfunctionJun 7, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THERE WAS AN ISSUE WITH AN XR DETECTABLE GAUZE. PHOTOS SHOWED SOME SORT OF TEARING OR QUALITY ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484979 ↗MalfunctionMay 1, 2024Material Frayed; Material Frayed
THE CUSTOMER REPORTED SEVERAL OF THE X-RAY DETECTABLE SPONGES HAVE BEEN STICKING TO THE PACKAGING. THIS REQUIRES VIGOROUS SHAKING TO GET THEM ON THE STERILE FIELD; ALSO CAUSING FRAYING OF THE SPONGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220381 ↗MalfunctionJan 29, 2024Misassembled; Misassembled
THE CUSTOMER REPORTED THERE WERE 11 RAYTEC GAUZE IN THE PACK VERSUS 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18595393 ↗MalfunctionJan 24, 2024Component Missing; Component Missing
THE CUSTOMER REPORTED THAT ONLY 9 GAUZE/SPONGES WERE NOTED IN THE TOTAL HIP PACK. THERE WERE SUPPOSED TO BE 10 IN THE PACK. MEDICAL INTERVENTION WAS NOT APPLICABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18570487 ↗MalfunctionJan 17, 2024Material Frayed; Material Frayed
THE CUSTOMER REPORTED THAT THE RAYTEC SHREDDED INSIDE A PATIENT. IN ONE INSTANCE THEY SPENT A SIGNIFICANT AMOUNT OF TIME PULLING OUT FRAYED AND SPLIT FIBERS FROM A PATIENT AFTER PACKING. THERE WERE NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18525686 ↗MalfunctionJan 6, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED THAT, DURING A SURGICAL CASE, THE SPONGE WAS OPENED AND THE BLUE X-RAY DETECTABLE LINE BEGAN TO COME OUT. IT WAS TAKEN OUT OF THE ROOM AND REPLACED WITH A DIFFERENT BRAND WITHOUT ISSUES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18461177 ↗MalfunctionNov 27, 2023Component Missing; Component Missing
CUSTOMER REPORTS: WHEN OPENING THE PACK OF RAYTEC, THERE WERE ONLY 9 EACH INSTEAD OF 10 EACH. THIS HAPPENED IN 5 SEPARATE PACKS OF RAYTEC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18209141 ↗MalfunctionNov 10, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
CUSTOMER REPORTS: THERE WAS A MISCOUNT OF THE 4X8 SPONGES IN THE FIELD DURING A CRITICAL TIME OF THE CASE. THE SPONGES HAD 13 INSTEAD OF 10. THE SPONGES WERE DISPOSED OF BECAUSE THEY WERE IN THE FIELD AND CONTAMINATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18115798 ↗MalfunctionOct 25, 2023Component Missing; Component Missing
THE CUSTOMER REPORTED THAT PER THE ATTACHED PICTURE THE BLUE X-RAY DETECTABLE STRING IS NOT THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18005765 ↗MalfunctionSep 13, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED THAT WHEN DOING THEIR INITIAL COUNT FOR THEIR RAYTEC SPONGES, THEY ONLY HAD 9 SPONGES IN THE PACK (SHOULD HAVE HAD 10). THERE WAS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17736540 ↗MalfunctionSep 5, 2023Material Separation; Material Separation
CUSTOMER REPORTS: THE RAYTEX SPONGE BREAKS DOWN INTO SMALL PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17686110 ↗
Other Cardinal Health, Inc. products
All Cardinal Health, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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