Vistec 7318 (UDI 00884527017006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00884527017006), received between Jun 13, 2017 and Jun 7, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 5, 2023Material Separation; Material Separation

  CUSTOMER REPORTS: RAYTEX SPONGE BREAKS DOWN INTO SMALL PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685982 ↗
• MalfunctionSep 9, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED THAT THERE WERE 11 SPONGES IN THE PACK INSTEAD OF 10, AS IT SUPPOSED TO BE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446255 ↗
• MalfunctionApr 26, 2021Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED PARTICLES IN THE GAUZE AND THE FIBERS OF THE GAUZE BREAK DOWN. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725777 ↗
• MalfunctionApr 1, 2021Particulates; Particulates

  CUSTOMER REPORTS: THERE ARE PARTICLES IN THE GAUZE AND THE FIBERS BREAK DOWN. THIS IS FOR USE IN THE OPERATING ROOM.

  Patient problems: Insufficient Information

  MAUDE report 11604354 ↗
• MalfunctionApr 1, 2021Particulates; Particulates

  CUSTOMER REPORTS: THERE ARE PARTICLES IN THE GAUZE AND THE FIBERS BREAK DOWN. THIS IS FOR USE IN THE OPERATING ROOM.

  Patient problems: Insufficient Information

  MAUDE report 11604302 ↗
• MalfunctionFeb 17, 2021Material Disintegration

  THE CUSTOMER REPORTED THE COMPRESS IS LINTING. ADDITIONAL INFORMATION RECEIVED STATED THIS WAS NOTICED BEFORE USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338820 ↗
• MalfunctionJul 27, 2020Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THE FIBERS OF THE GAUZE ARE FRAYING WITHOUT BEING UNFOLDED OR UNROLLED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10326230 ↗
• MalfunctionJul 27, 2020Material Frayed; Material Frayed

  THE CUSTOMER STATES THE FIBERS OF THE GAUZE ARE FRAYING. THE PRODUCT WAS USED TO SOAK UP BLOOD AT THE SURGICAL SITE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10325609 ↗
• MalfunctionJul 17, 2020Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THAT THERE HAVE BEEN REPORTS BY THE STAFF THAT THE BLUE RADIOPAQUE THREAD HAS LOOSENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10289942 ↗
• MalfunctionJan 9, 2020Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE X-RAY DETECTABLE THREAD CAME OUT OF THE GAUZE SPONGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9570088 ↗
• MalfunctionDec 13, 2019Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE X-RAY DETECTABLE THREAD CAME OUT OF THE GAUGE SPONGE DURING USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9467984 ↗
• MalfunctionSep 16, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE SPONGES WERE LINTING.

  Patient problems: No Patient Involvement

  MAUDE report 9071582 ↗
• MalfunctionSep 13, 2017Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THAT DURING A HEAD <(>&<)> NECK PROCEDURE, THE DEVICE WAS NOT INTACT, LEAVING SPONGE PARTICLES IN THE PATIENT'S SURGICAL WOUND. THE CUSTOMER FURTHER REPORTS THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6862507 ↗
• MalfunctionJun 13, 2017Material Frayed; Material Frayed

  THE CUSTOMER STATES THE SPONGES ARE FRAYING AND LEAVES A LINT BEHIND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6636680 ↗