Vistec 7317 (REF 7317--)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 20192253047285), received between Apr 22, 2025 and Apr 21, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (10 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Component Missing

  THE CUSTOMER REPORTED A PACKET OF CARDINAL HEALTH BRAND VISTEC X-RAY DETECTABLE SPONGES HAD ONLY 9 SPONGES INSTEAD OF TEN. PER THE CUSTOMER, THIS SHORTAGE CREATES A POSSIBLE ISSUE IN ACCOUNTING FOR THE NUMBER OF SPONGES USED DURING SURGICAL PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938813 ↗
• MalfunctionMar 26, 2026Material Fragmentation

  THE CUSTOMER REPORTED THE MATERIAL IS SHEDDING FIBERS AND LEAVING PARTICLES ON THE SURGICAL FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706387 ↗
• MalfunctionJan 9, 2026Component Missing

  THE CUSTOMER REPORTED ONLY 9 EA SPONGES INSIDE THE SEALED TRAY. THE KIT COULD NOT BE USED SINCE ALL 10 EACH WEREN'T ACCOUNTED FOR IN THE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019971 ↗
• MalfunctionDec 10, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THEY OPENED TWO PACKS AND RUBBED THEM AROUND AND NOTED THAT THEY ALSO WERE LEAVING BEHIND TINY THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772105 ↗
• MalfunctionDec 10, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, AN ADDITIONAL PACK OF RAYTEC WAS OPENED TO THE FIELD. WHEN USING, IT WAS NOTICED THAT THEY WERE LEAVING TINY THREADS OF THE RAYTEC BEHIND. THE CIRCULATOR OPENED ANOTHER PACK AND RUBBED THEM AROUND AND NOTED THAT THEY ALSO WERE LEAVING BEHIND TINY THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772089 ↗
• MalfunctionNov 5, 2025Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THE CARDINAL VISTEC XRAY DETECTABLE SPONGE PACK LOT # 25C019262 CONTAINED ONLY NINE SPONGES INSTEAD OF TEN SPONGES. ON 17NOV2025, THE IN CUSTOMER STATED THAT THE ISSUE WAS IDENTIFIED BEFORE THE PRODUCT WAS PLACED INTO CLINICAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479902 ↗
• MalfunctionSep 12, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE PRODUCT IS LINTING REALLY BAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042637 ↗
• MalfunctionSep 12, 2025Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT TWO ONLY HAD 9 IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042631 ↗
• MalfunctionSep 12, 2025Component Missing; Component Missing

  THE CUSTOMER REPORTED THE PRODUCT CONTAINED ONLY 9 SPONGES INSTEAD OF 10 SPONGES WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042371 ↗
• MalfunctionSep 11, 2025Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THERE WAS ONLY 9 IN THE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025903 ↗
• MalfunctionAug 26, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THEY HAD A COUPLE OF RAYTECS OPENED (NOT IN PACKS) THAT WERE SHEDDING WHEN IN USE. THE SURGEON HAD TO IRRIGATE IT WAS SO BAD. THEY OPENED 2 OF THESE WITH THE SAME RESULTS. ON (B)(6) 2025 THE CUSTOMER STATED THAT THEY OPENED BOTH ON THE SAME CASE. THE RAYTECS WERE UNFOLDED WHEN USED THEN DISCARDED. IT WAS STATED THAT IRRIGATING PROFUSELY IS ALL THAT WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894662 ↗
• MalfunctionJun 11, 2025Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  THE CUSTOMER REPORTED EXCESSIVE LINTING AND LONG STRANDS FALLING OFF THE SPONGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22189144 ↗
• MalfunctionJun 11, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE SPONGES ARE FLAKING SMALL FIBERS/DEBRIS. THE FEAR IS FOREIGN BODY IN THE WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188862 ↗
• MalfunctionJun 2, 2025Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  THE CUSTOMER REPORTED EXCESSIVE LINTING AND LONG STRANDS FALLING OFF THE SPONGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125519 ↗
• MalfunctionMay 27, 2025Material Fragmentation; Material Frayed; Material Fragmentation; Material Frayed

  THE CUSTOMER REPORTED SHREDDING AND HIGH AMOUNTS OF LINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087653 ↗
• MalfunctionMay 27, 2025Material Fragmentation; Material Frayed; Material Fragmentation; Material Frayed

  THE CUSTOMER REPORTED SHREDDING AND HIGH AMOUNTS OF LINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087645 ↗
• MalfunctionApr 22, 2025Material Disintegration; Material Disintegration

  THE CUSTOMER REPORTED THAT THE PRODUCT WAS RECEIVED WITH LINT ON IT BUT THE ITEM CLAIMED TO BE "LINT FREE". ON (B)(6) 2025 THE CUSTOMER CLARIFIED THAT THESE SPONGES ARE ¿SHEDDING¿ THEY DON¿T HAVE LINT ON THEM. THEY ARE DROPPING SHREDS OF THE THIN FIBERS. THE CUSTOMER STATED THAT THEY PULLED ONE FROM THIS LOT, 24J019662, FROM INVENTORY TO TEST AND WITH NORMAL OPENING IT SHED AND WITH VIGOROUS MANIPULATION IT SHED A LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881212 ↗
• MalfunctionApr 22, 2025Material Disintegration; Material Disintegration

  THE CUSTOMER REPORTED THAT THE PRODUCT WAS RECEIVED WITH LINT ON IT BUT THE ITEM CLAIMED TO BE "LINT FREE". ON (B)(6) 2025 THE CUSTOMER CLARIFIED THAT THESE SPONGES ARE ¿SHEDDING¿ THEY DON¿T HAVE LINT ON THEM. THEY ARE DROPPING SHREDS OF THE THIN FIBERS. THE CUSTOMER STATED THAT THE PRODUCT WAS BEING UNFOLDED ON THE STERILE FIELD, BUT NOT OVER THE PATIENT, SCRUB TECH NOTICED THE ¿SHEDDING¿ AS THE SPONGE WAS BEING UNFOLDED OVER THE MAYO STAND ¿ THAT WAS SPECIFICALLY LOT# 25B023062 ¿ THE SPONGE AND REMAINING OPENED PRODUCT USED IN THE ACTUAL CASE WAS DISCARDED. AFTER THE INITIAL COMPLAINT THEY PULLED ANOTHER ITEM OF THE SAME LOT# TO SEE IF THEY COULD DUPLICATE THE ISSUE. AND THEY DID, WITH NORMAL OPENING IT SHED, WITH VIGOROUS MANIPULATION IT SHED A LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881209 ↗
• MalfunctionApr 22, 2025Material Disintegration; Material Disintegration

  THE CUSTOMER REPORTED THAT THE SPONGES ARE ¿SHEDDING¿, THEY ARE DROPPING SHREDS OF THE THIN FIBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881206 ↗