Vistec 7317 (UDI 10884527016990)Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10884527016990), received between Apr 12, 2017 and Aug 7, 2025 — classified as 1 injury, 79 malfunctions.

The most frequently reported specific device problem is “Material Separation” (17 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 17, 2017Terminated

   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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionJun 30, 2023Component Misassembled; Component Misassembled

  THE CUSTOMER REPORTED THAT THE PACK OF TEN HAD ONLY 8 SPONGES IN THE PACK. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239119 ↗
• MalfunctionMar 10, 2023Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THAT THE PRODUCT IS UNRAVELING OR FRAYING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522955 ↗
• MalfunctionMar 2, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  MULTIPLE DEPARTMENTS ARE REPORTING THAT THE PRODUCT IS UNRAVELING OR FRAYING WHILE IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469802 ↗
• MalfunctionFeb 22, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  THE CUSTOMER REPORTED THE RAYTECS ARE TOO THIN AND FRAYING. WHEN THEY ARE WET, THEY FALL APART. THE CUSTOMER IS USING THIS PRODUCT IN PLACE OF THEIR REGULAR PRODUCT WHICH IS ON BACKORDER. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416415 ↗
• MalfunctionFeb 7, 2023Component Missing; Component Missing

  THE CUSTOMER REPORTED ONLY 9 SPONGES IN THE PACK AND SHOULD HAVE BEEN 10 SPONGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315645 ↗
• MalfunctionJan 31, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  THE CUSTOMER REPORTED THE RAYTECS ARE TOO THIN AND FRAYING. WHEN THEY ARE WET, THEY FALL APART. THE CUSTOMER IS USING THIS PRODUCT IN PLACE OF THEIR REGULAR PRODUCT WHICH IS ON BACKORDER. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271229 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE PRODUCT IS SHREDDING BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194585 ↗
• MalfunctionNov 7, 2022Component Missing; Component Missing

  THE CUSTOMER REPORTED THERE WERE NINE SPONGES IN THE PACK AND THERE SHOULD BE TEN. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744658 ↗
• MalfunctionOct 27, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THE PRODUCT IS SHEDDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679329 ↗
• MalfunctionAug 25, 2022Component Missing; Manufacturing, Packaging or Shipping Problem

  DURING A SIMULATION OF AN OPERATING ROOM EVENT, THE NURSE WAS SHOWING HOW TO EMPTY A PACKAGE OF VISTEC XRAY DETECTABLE SPONGES (10 COUNT) ON THE STERILE FIELD USING STERILE TECHNIQUE. AFTER OPENING THE PACK, WHEN SHE DUMPED, ONE SPONGE REMAINED PARTIALLY ADHERED TO PACK. WHEN WE COUNTED THE SPONGES THAT REMAINED IN THE PAPER WRAP, ONLY 9 WERE WRAPPED.

  Patient problems: Insufficient Information

  MAUDE report 15292832 ↗
• MalfunctionAug 23, 2022Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THAT THE VISTEC X-RAY DETECTABLE SPONGES ARE OUT OF THE PACKAGE NOTICEABLY FRAYING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280116 ↗
• MalfunctionJun 17, 2022Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THEY OPENED A BOX OF RAYTEC SPONGES AND THERE WERE ONLY 9 IN THE BOX. PER ADDITIONAL INFORMATION RECEIVED ON 14JUN2022, THE CUSTOMER CLARIFIED THAT THE INDIVIDUAL PACKAGE WAS MISSING ONE GAUZE OUT OF 10 GAUZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14732074 ↗
• MalfunctionMay 31, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE RAYTECS WERE SHREDDING WHEN BEING REMOVED FROM THE PATIENT. PER CUSTOMER, THE ORIGINAL INTENDED PROCEDURE WAS ROBOTIC PARAOESOPHAGEAL HERNIA REPAIR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547106 ↗
• MalfunctionMay 18, 2022Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT A PACK OF 4X8 RADIOPAQUE GAUZE ONLY HAD 9 SPONGES IN THE SET INSTEAD OF 10. ADDITIONAL INFORMATION RECEIVED ON 16-MAY-2022 FROM THE INITIAL REPORTER STATED THAT THE ISSUE WAS FOUND WHEN THEY OPENED THE PACKAGE TO COUNT ITEMS PRIOR TO USE. THE SPONGES WERE HANDED OFF IMMEDIATELY AND NOT USED ON PATIENT. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427294 ↗
• MalfunctionApr 25, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THEY RECEIVED A CALL FROM THE OPERATING ROOM AND THE GAUZE IS SHREDDING WHEN BEING USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197104 ↗
• MalfunctionApr 25, 2022Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THAT THE GAUZE SEEMS TO HAVE A TIGHTER WEAVE, BUT THEY NOTICED FRAYING ON THE EDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197076 ↗
• MalfunctionApr 25, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THEY RECEIVED A CALL FROM THE OPERATING ROOM AND THE GAUZE IS SHREDDING WHEN BEING USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197004 ↗
• MalfunctionApr 12, 2022Packaging Problem; Packaging Problem

  CUSTOMER REPORTS: THERE WAS 12 RAYTEC SPONGES INSTEAD OF 10 PER PACK INSIDE ONE PACKAGE OF STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14086812 ↗