NGage G48297Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 00827002482975), received between Jul 25, 2016 and Aug 6, 2025 — classified as 1 injury, 95 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (54 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 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Break; Break

  THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731699 ↗
• MalfunctionJun 20, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR¿S BASKET WAS UNABLE TO FUNCTION PROPERLY DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297696 ↗
• MalfunctionJun 12, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THE DOCTOR TRIED TO TEST THE NGAGE NITINOL STONE EXTRACTOR PRIOR TO USE AND FOUND IT COULD BE OPENED BUT COULD NOT BE CLOSED. AFTER CLOSING IT MANUALLY, THE DOCTOR PLACED IT INTO THE PATIENT´S BODY AND FOUND IT COULD NOT BE OPENED. THE DOCTOR USED ANOTHER EXTRACTOR TO REPLACE IT AND COMPLETED THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199145 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED A WIRE OF THE NGAGE NITINOL STONE EXTRACTOR¿S BASKET BROKE DURING A RETROGRADE INTRARENAL SURGERY (RIRS) OF LEFT KIDNEY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134174 ↗
• MalfunctionMay 6, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR WAS TESTED BEFORE A RETROGRADE INTRARENAL SURGERY (RIRS) TO REMOVE A STONE LOCATED IN THE RIGHT KIDNEY, THE TEST WAS NORMAL; HOWEVER, THE BASKET COULD NOT BE OPENED DURING THE 6TH STONE REMOVAL. THE FOLLOW UP OPERATION WAS COMPLETED AFTER OPENING A NEW BASKET. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21972877 ↗
• MalfunctionApr 18, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED AN NGAGE NITINOL STONE EXTRACTOR WAS INSERTED INTO A FLEXIBLE URETEROSCOPE FORCEPS CHANNEL FOR A TRANSURETHRAL URETEROLITHOTRIPSY PROCEDURE TO REMOVE STONES, HOWEVER, THE BASKET WAS UNABLE TO OPEN AT THE TARGET SITE UPON THE FIRST ATTEMPT. THE DEVICE WAS REPLACED WITH ANOTHER NEW SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THE PRODUCT WAS TESTED PRIOR TO USE. A LASER WAS NOT USED WHILE THE BASKET WAS USED. THE PATIENT´S ANATOMY DID NOT KEEP THE BASKET FROM OPENING OR CLOSING. THE HANDLE WAS NOT IN A STRAIGHT POSITION TOWARDS THE PATIENT´S BODY OR POINTED TOWARDS THE CEILING. NO STONES WERE CAPTURED, AND NO PART OF THE BASKET WAS SEPARATED. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866929 ↗
• MalfunctionApr 17, 2025Difficult to Open or Close; Difficult to Open or Close

  INFORMATION RECEIVED 21APR2025, UPDATING THE PATIENTS AGE TO 64 YEARS OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857780 ↗
• MalfunctionApr 1, 2025Difficult to Open or Close; Difficult to Open or Close

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739091 ↗
• MalfunctionMar 31, 2025Break; Break

  IT WAS REPORTED DURING A HOLMIUM LASER LITHOTRIPSY WITH URETERAL FLEXIBLE ENDOSCOPE TO REMOVE THE STONE LOCATED IN THE LEFT KIDNEY, THE BASKET WIRE OF NGAGE NITINOL STONE EXTRACTOR WAS BROKEN. THE USER REMOVED THE STONE WITH THE BASKET THAT FUNCTIONED 2-3 TIMES SUCCESSFULLY, THEN OBSERVED THE BASKET WIRE WAS BROKEN. A NEW BASKET 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21733456 ↗
• MalfunctionFeb 13, 2025Difficult to Open or Close; Material Split, Cut or Torn; Difficult to Open or Close; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BASKET OF 'NGAGE NITINOL STONE EXTRACTOR' WOULD NOT OPEN OR CLOSE DURING TRANSURETHRAL URINARY STONE REMOVAL PROCEDURE. THE ISSUE WAS DISCOVERED WHEN THE USER TRIED TO OPEN THE BASKET TO GRASP THE STONE IN THE URINARY DUCT UNDER AN ENDOSCOPE, BUT IT FAILED TO OPEN. A LASER WAS NOT IN USE AT THE TIME. THE USER REMOVED FROM PATIENT'S BODY AND TRIED TO OPERATE OUTSIDE THE BODY, BUT THE BASKET FAILED TO OPEN. NO PART WAS SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER BASKET. IT IS UNKNOWN IF THE DEVICE WAS TESTED PRIOR TO USE ALTHOUGH IT WAS POSSIBLE TO CLOSE IT FROM THE OPEN POSITION BEFORE INSERTION. REPORTEDLY, THE DEVICE WAS IN THE UNCOILED POSITION AT THE TIME. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO SECTION OF THE DEVICE REMAINS INSIDE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374655 ↗
• MalfunctionJan 7, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE AN NGAGE NITINOL STONE EXTRACTOR WAS USED. THE DOCTOR WAS ABLE TO OPEN THE BASKET, BUT THE BASKET WOULD NOT FULLY CLOSE AND FAILED TO CATCH THE STONE SUCCESSFULLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558375 ↗
• MalfunctionDec 31, 2019Difficult to Open or Close; Difficult to Open or Close

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536116 ↗
• MalfunctionDec 31, 2019Difficult to Open or Close; Difficult to Open or Close

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9535914 ↗
• MalfunctionDec 31, 2019Difficult to Open or Close; Difficult to Open or Close

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9535901 ↗
• MalfunctionDec 19, 2019Difficult to Open or Close; Difficult to Open or Close

  NO NEW PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9497639 ↗
• MalfunctionOct 10, 2019Difficult to Open or Close; Difficult to Open or Close

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON 10OCT2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9174815 ↗
• MalfunctionAug 27, 2019Break; Break

  IT WAS REPORTED, DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE TO REMOVE A 10 MM STONE USING A NGAGE NITINOL STONE EXTRACTOR, THE OPERATOR OPENED THE DEVICE AND DISCOVERED THE BASKET WAS DAMAGED. IT WAS OBSERVED THAT ONE OF THE WIRES WAS NOT ATTACHED ON THE TIP OF THE BASKET PRIOR TO PATIENT CONTACT. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8934949 ↗
• MalfunctionAug 12, 2019Difficult to Open or Close; Difficult to Open or Close

  ADDITIONAL INFORMATION RECEIVED (B)(6)2019: IT WAS ADVISED THAT THERE WAS NO ISSUE WITH THE DEVICE. THE CUSTOMER WAS USE TO USING ANOTHER DEVICE THAT HAS A LARGER DIAMETER BASKET. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE USING THE COMPLAINT DEVICE. THE PROCEDURE BEING PERFORMED WAS A FLEXIBLE LITHOTOMY IN THE KIDNEY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8885142 ↗
• MalfunctionApr 10, 2019Difficult to Open or Close; Difficult to Open or Close

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500515 ↗
• MalfunctionMar 22, 2019Mechanical Jam; Mechanical Jam

  NO NEW EVENT INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8443367 ↗
• MalfunctionMar 11, 2019Difficult to Open or Close; Difficult to Open or Close

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409094 ↗
• MalfunctionFeb 28, 2019Difficult to Open or Close; Difficult to Open or Close

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377761 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR WAS USED DURING A FLEXIBLE URS IN THE KIDNEY FOR STONE EXTRACTION. TWO CONCREMENTS WERE ABLE TO BE REMOVED. AFTER GRABBING THE THIRD PARTICLE OF STONE, ONE OF THE WIRES OF THE BASKET RIPPED. THE BROKEN BASKET WAS REMOVED WITHOUT ANY PROBLEM AND A SECOND NGAGE WAS OPENED AND THE PROCEDURE COMPLETED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8173647 ↗
• MalfunctionDec 14, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED 14DEC2018. THIS WAS A CYSTO WITH STONE REMOVAL PROCEDURE. THE BASKET NEVER TOUCHED THE PATIENT, THE ISSUE WAS REALIZED BEFORE IT REACHED THE PATIENT. THE STONES WERE REMOVED WITH ALTERNATE BASKETS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8164662 ↗
• MalfunctionDec 3, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS INITIALLY REPORTED THE NGAGE NITINOL STONE EXTRACTOR BASKET DID NOT OPEN PROPERLY IN THE KIDNEY. THE PATIENT WAS NOT HARMED. THE HANDLE CLICKS, WHEN OPENING THE BASKET. THE BASKET JUMPS OPEN INSTEAD OF OPENING SMOOTHLY. ADDITIONAL INFORMATION RECEIVED ON 30NOV2018. THE REPRESENTATIVE REPORTED HE TALKED TO THE CUSTOMER AGAIN. UNFORTUNATELY, HE COULD NOT GIVE ME THE ADDITIONAL INFORMATION REQUESTED. HE DESCRIBED THE INCIDENT AS THE FOLLOWING: FLEXIBLE URS FOR STONE TREATMENT WAS PERFORMED. AFTER DEFLECTING THE ENDOSCOPE IN THE LOWER CALYX, THE NGAGE WAS ADVANCED THROUGH THE WORKING CHANNEL TO THE FRAGMENT. THE BASKET DID NOT OPEN PROPERLY IN THE CALYX. THEY REMOVED THE NGAGE FROM THE ENDOSCOPE AND MADE A DRY FUNCTIONAL TEST OUTSIDE OF THE PATIENT. THE BASKET DID NOT OPEN SMOOTHLY BUT JUMPED OPEN. THE CUSTOMER OPENED A SECOND NGAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125872 ↗