Atlas Wire G32824Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002328242), received between Jul 3, 2019 and Oct 12, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A UNILATERAL RIGID URETERORENAL LITHOTRIPSY PROCEDURE, THE TIP OF THE EXTRACTOR, LOCATED BEFORE THE BASKET, WAS CRACKED. A NEW SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928203 ↗
• MalfunctionOct 22, 2020Material Frayed; Material Frayed

  AS REPORTED, PRIOR TO USE IN A RIGID URETERORENOLITHOTRIPSY PROCEDURE, THE EXTRACTOR WIRE OF A ATLAS-WIRE STONE EXTRACTOR FRAYED WHEN TESTING THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10718736 ↗
• MalfunctionSep 29, 2020Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599688 ↗
• MalfunctionJul 3, 2019Material Separation; Difficult to Open or Close; Material Separation; Difficult to Open or Close

  IT WAS INITIALLY REPORTED THAT DURING A FLEXIBLE URETEROSCOPY WITH LASER LITHOTRIPSY THROUGH A FLEXOR URETERAL ACCESS SHEATH, MULTIPLE COOK EXTRACTOR DEVICES MALFUNCTIONED AND WOULD NOT OPEN, INCLUDING ONE DEVICE SEPARATING (REPORTED UNDER PATIENT IDENTIFIERS (B)(6)). ULTIMATELY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER COOK EXTRACTOR DEVICE. FIVE (5) DEVICES WERE RETURNED TO THE MANUFACTURER. UPON COMPLETION OF THE DEVICE FAILURE ANALYSIS FORMS ON 02JUL2019 THE FOLLOWING INFORMATION HAS BEEN PROVIDED: TWO (2) NCIRCLE TIPLESS STONE EXTRACTOR DEVICES WERE RETURNED. THE FIRST DEVICE, (REPORTED UNDER PATIENT IDENTIFIER (B)(6)) WAS NOTED TO MALFUNCTION IN TERMS OF NOT OPENING AND CLOSING PROPERLY. THE SECOND DEVICE (REPORTED UNDER PATIENT IDENTIFIER 270371) WAS NOTED TO BE "SEVERED" OR SEPARATED. THREE (3) ATLAS-WIRE STONE EXTRACTOR DEVICES WERE RETURNED. DURING THE INVESTIGATION, IT WAS DISCOVERED THAT ALL THREE OF THESE DEVICES WERE NOTED TO MALFUNCTION IN TERMS OF NOT OPENING AND CLOSING PROPERLY. IT WAS INITIALLY REPORTED THAT TWO OF THE ATLAS-WIRE STONE EXTRACTOR DEVICES MALFUNCTIONED IN TERMS OF NOT OPENING AND CLOSING PROPERLY AND WERE MISTAKENLY REPORTED (REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8759749 ↗