Vistec 7462 (UDI 10884527017065)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884527017065), received between Oct 4, 2019 and Jul 19, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2023Component Missing; Component Missing

  THE CUSTOMER REPORTED THE ITEM ONLY CONTAINED 9 IN THE SET OF 10. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17353390 ↗
• MalfunctionOct 5, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED THAT THE ITEM ONLY CONTAINED 9 PIECES OF GAUZE. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543769 ↗
• MalfunctionMay 17, 2021Component Missing; Component Missing

  THE CUSTOMER REPORTED PACK ONLY CONTAINED 9 PIECES OF GAUZE INSTEAD OF 10. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838199 ↗
• MalfunctionApr 6, 2021Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THEY RECEIVED A PACK ONLY CONTAINING 9 PIECES OF GAUZE INSTEAD OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625224 ↗
• MalfunctionApr 1, 2021Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED RECEIVING 13 X-RAY GAUZE INSIDE THE PACK INSTEAD OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605517 ↗
• MalfunctionAug 17, 2020Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THE PACK WAS SUPPOSED TO HAVE 10 SPONGE GAUZE IN IT, BUT IT ONLY HAD 9. THE COUNTING METHOD IS MANUAL AND THE MISCOUNT WAS IDENTIFIED DURING INITIAL COUNT PRIOR TO COMMENCEMENT OF SURGERY. NO PATIENT INVOLVED, NO INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 10413112 ↗
• MalfunctionAug 12, 2020Component Missing; Component Missing

  THE CUSTOMER REPORTED THE PACK WAS SUPPOSED TO HAVE 10 SPONGES, BUT ONLY HAD 9.

  Patient problems: No Consequences Or Impact To Patient; Urinary Retention

  MAUDE report 10396441 ↗
• MalfunctionJan 17, 2020Packaging Problem; Packaging Problem

  THE CUSTOMER REPORTED THAT THEY DISCOVERED AN ADDITIONAL SPONGE WITHIN THE BUNDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9601717 ↗
• MalfunctionOct 4, 2019Material Disintegration; Material Disintegration

  THE CUSTOMER STATES THE GAUZE WAS LINTING. THIS WAS NOTICED PRIOR TO USE.

  Patient problems: No Patient Involvement

  MAUDE report 9156862 ↗