Vistec 7148 (UDI 10884527016969)Recalls & reported problems
Cardinal Health, Inc. · X-Ray Detectable Sponges,16 Ply · Class 1
Quick summary
These are Cardinal Health Vistec x-ray detectable surgical gauze sponges used to pack wounds and absorb blood. The 27 reports mostly describe sponges arriving with the wrong count in a pack (nine or eleven pieces instead of ten) and material fraying or breaking apart, including fibers pulling apart inside a patient during packing. No deaths or injuries were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884527016969), received between May 8, 2019 and Dec 26, 2025 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Component Missing” (11 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Component Missing11
- Material Frayed4
- Device Misassembled During Manufacturing /Shipping2
- Material Fragmentation2
- Nonstandard Device2
- Packaging Problem2
- Defective Component1
- Incomplete or Missing Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient4
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 27 reports, 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 ↗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 ↗MalfunctionAug 21, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED THAT ONLY 9 GAUZES 4 X 4 XR SPONGES WERE FOUND IN THE TOTAL HIP PACK. THERE WAS NO HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE DEFECTIVE PRODUCT ONLY HAD 9 INDIVIDUAL PIECES OF GAUZE IN THE STACK WHEN IT SHOULD HAVE BEEN 10. PER CUSTOMER, 1 STACK IS EQUAL TO 1 DEFECTIVE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17584746 ↗MalfunctionMay 18, 2023Unraveled Material; Unraveled Material
THE CUSTOMER REPORTED THAT THEY HAD TWO PACKS OF COVIDIEN RAYTEC X-RAY DETECTABLE SURGICAL SPONGES THAT HAD THE X-RAY DETECTABLE BLUE STRIP UNRAVEL OUT OF THE SPONGE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT IT APPEARS THAT THE SPONGES, IN GENERAL, ARE DESIGNED WITH THE ABILITY OF THE BLUE STRIP TO EASILY COME OUT WHEN THE SPONGES ARE OPENED. THE ISSUE WAS DISCOVERED DURING A CASE; HOWEVER, NO PATIENT WAS INVOLVED AS THE SPONGE WERE TAKEN OUT OF THE ROOM AND DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16956446 ↗MalfunctionNov 8, 2022Component Missing; Component Missing
CUSTOMER REPORTS: THE FIRST PACKAGE CONTAINED 9 INSTEAD OF A 10 COUNT OF GAUZE, AND THE SECOND PACK WITH THE SAME LOT NUMBER CONTAINED 11 INSTEAD OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15752789 ↗MalfunctionMar 24, 2022Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE STACK HAD NINE INSTEAD OF TEN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13896503 ↗MalfunctionMar 23, 2022Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTED THE STACK HAD 11 EACH INSTEAD OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869380 ↗MalfunctionJan 27, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED THAT THERE WAS A MISCOUNT OF GAUZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13366226 ↗MalfunctionNov 23, 2021Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE GAUZE WAS MISSING THE RADIOPAQUE MARKER ON ONE SIDE. THE ISSUE WAS DISCOVERED DURING SETUP. THERE WAS NO PATIENT HARM AND THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12861115 ↗MalfunctionNov 11, 2021Defective Component
RAYTEC GAUZE MISSING RADIOPAQUE MARKER ON ONE SIDE OF THE GAUZE. GAUZE WAS CONTAINED WITHIN ROI CPS, LLC CUSTOM PROCEDURE KIT-880085, LOT 21116472691. RAYTEC WAS DISCARDED AND A NEW TUB OF GAUZE WAS PULLED FROM INVENTORY. NO HARM TO PATIENT AND NO DELAY TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12800347 ↗MalfunctionMay 10, 2021Packaging Problem; Packaging Problem
THE CUSTOMER REPORTED THAT TWO PACKS OF VISTEC X-RAY DETECTABLE GAUZE SPONGES HAD 11 SPONGES INSTEAD OF 10. THE RAYTEC WAS PULLED FROM THEIR INVENTORY. THERE WAS NO HARM TO THE PATIENT OR DELAY TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11802731 ↗MalfunctionDec 17, 2020Component Missing; Component Missing
THE CUSTOMER REPORTED THAT ONLY 9 OF 10 RAYTEC SPONGES INSIDE OF BAND. THE ISSUE WAS DISCOVERED DURING SET UP. NO HARM TO THE PATIENT. NO DELAY TO THE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11033499 ↗MalfunctionDec 13, 2020Material Frayed; Material Frayed
THE CUSTOMER REPORTED THEY FOUND FRAYED RAYTEC. THIS DID NOT DELAY THE PROCEDURE, NO PATIENT HARM AND WAS DISCOVERED BEFORE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10998532 ↗MalfunctionSep 28, 2020Material Frayed; Material Frayed
THE CUSTOMER REPORTED THAT THE VISTEC SPONGES WERE FOUND TO BE FRAYED. THE ISSUE WAS DISCOVERED BEFORE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE AND NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10594067 ↗MalfunctionMar 3, 2020Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE BUNDLE ONLY HAS 9 PIECES INSTEAD OF 10. THERE WAS NO PATIENT INJURED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9780908 ↗MalfunctionNov 27, 2019Incomplete or Missing Packaging; Incomplete or Missing Packaging
THE CUSTOMER REPORTED THAT THE GAUZE COUNT IS 7 INSTEAD OF 10.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9386810 ↗MalfunctionNov 25, 2019Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THEY SHOULD HAVE RECEIVED 10 EACH GAUZE BUT WAS MISSING ONE FROM THE PACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9369115 ↗MalfunctionOct 31, 2019Packaging Problem; Packaging Problem
THE CUSTOMER REPORTED THAT A PACK OF GAUZE CONTAINED 11 PIECES INSTEAD OF THE REQUIRED 10 PIECES. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE MISCOUNT WAS NOTICED DURING SETUP FOR THE PROCEDURE. THE EXTRA PIECE OF GAUZE WAS REMOVED FROM THE PACK AND THE REST OF THE GAUZE WAS USED FOR THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9263924 ↗MalfunctionOct 15, 2019Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE PRODUCT WAS COVERED WITH PARTICULATES. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE PARTICULATES FOUND IN THE GAUZE ARE FROM THE X-RAY DETECTABLE STRIP. THE ISSUE WAS NOTICE BEFORE USE. NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9194920 ↗MalfunctionOct 8, 2019Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THEY RECEIVED 9 PIECES OF GAUZE IN A PACK INSTEAD OF 10.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9168421 ↗MalfunctionSep 9, 2019Material Frayed; Material Frayed
THE CUSTOMER REPORTED THAT THE GAUZE WAS FRAYING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8976820 ↗MalfunctionJul 26, 2019Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTS THAT STRANDS/STRINGS HAVE BEEN FALLING OFF OF THE GAUZE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8832183 ↗MalfunctionJun 13, 2019Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE PACKAGE HAS 9 SPONGES INSTEAD OF 10.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8696454 ↗
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 55992CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
- AMD-RITMED 85995CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.