NGage G48294Recalls & reported problems
Cook Incorporated · NGage, Nitinol Stone Extractor · Class 2
Quick summary
This Cook NGage nitinol stone extractor is a basket tool used to remove stones from the ureter. Its 92 reports, with 1 injury and no deaths, often describe the basket being hard to open or close, and baskets breaking or splitting during use. Most reports describe no effect on patients. No recalls name this device. Reports for the last 12 months (0) are fewer than in the previous 12 months (18).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 92
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00827002482944), received between Sep 7, 2016 and Jun 5, 2025 — classified as 1 injury, 91 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (45 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close45
- Break25
- Device Operates Differently Than Expected5
- Material Deformation5
- Material Split, Cut or Torn5
- Device Damaged Prior to Use3
- Material Separation3
- Device Operational Issue2
Patient problems
- No Consequences Or Impact To Patient53
- No Clinical Signs, Symptoms or Conditions18
- No Known Impact Or Consequence To Patient16
- No Patient Involvement7
- No Information3
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, PRIOR TO PATIENT CONTACT, DURING AN INTRACORPOREAL LITHOTRIPSY PROCEDURE, THE DOCTOR REMOVED THE PACKAGE AND INSPECTED THE NGAGE NITINOL STONE EXTRACTOR AND FOUND THAT THE BASKET DID NOT OPEN AND CLOSE. THE DEVICE WAS NOT USED, AND ANOTHER 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 22151391 ↗MalfunctionMay 23, 2025Break; Break
IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THE USER ADVANCED THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR INTO THE PATIENT AND FOUND THE DEVICE DISTAL END BROKEN AFTER MULTIPLE ATTEMPTS. NO PIECES OF THE BASKET BROKE OFF OF THE DEVICE. A LASER WAS NOT USED AT THE SAME TIME AS THE BASKET. THE USER CHANGED TO A NEW BASKET TO COMPLETE THE PROCEDURE. 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 22081066 ↗MalfunctionMay 22, 2025Break; Break
IT WAS REPORTED DURING A RETROGRADE INTRARENAL SURGERY (RIRS), THE YELLOW SHEATH AND HANDLE OF A NGAGE NITINOL STONE EXTRACTOR WERE SEPARATED, SO THE BASKET COULD NOT BE OPENED OR CLOSED. A NEW PRODUCT 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. 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 22072357 ↗MalfunctionMay 14, 2025Break; Break
IT WAS REPORTED WHEN THE USER OPENED THE PACKAGE OF AN NGAGE NITINOL STONE EXTRACTOR IT WAS FOUND THE DEVICE TIP WAS BROKEN. THE USER CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS ON PATIENT WERE REPORTED SINCE THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22019994 ↗MalfunctionMay 2, 2025Break; Break
IT WAS REPORTED DURING A FLEXIBLE URETEROSCOPY FOR STONE REMOVAL, THE USER DETECTED THE BASKET WIRE OF AN NGAGE NITINOL STONE EXTRACTOR WAS BROKEN, IT COULD NOT BE OPENED AFTER INITIAL USE, AND THE OPEN AND CLOSE BUTTON COULD BE MOVED. THE USER CHANGED TO A NEW SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. A VIDEO OF WHAT APPEARS TO SHOW A BASKET WIRE BROKEN WAS PROVIDED. 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 21955617 ↗MalfunctionMay 1, 2025Break; Break
IT WAS REPORTED, DURING A FLEXIBLE URETEROSCOPY PROCEDURE, THE USER DETECTED THE BASKET WIRE OF AN NGAGE NITINOL STONE EXTRACTOR WAS BROKEN. THE USER IMMEDIATELY CHANGED TO A NEW BASKET TO COMPLETE THE PROCEDURE. A VIDEO OF WHAT APPEARS TO SHOW A BASKET WIRE BROKEN WAS PROVIDED. 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 21944736 ↗MalfunctionMay 1, 2025Break; Break
IT WAS REPORTED DURING A FLEXIBLE URETEROSCOPY FOR STONE REMOVAL, THE WIRE OF THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR WAS BROKEN AFTER ONE USE. IT WAS OBSERVED THE OPEN AND CLOSE BUTTON WAS ABLE TO BE MOVED. A NEW BASKET OF THE SAME BATCH WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. A VIDEO OF WHAT APPEARS TO SHOW A BROKEN WIRE WAS PROVIDED. 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 21944552 ↗MalfunctionApr 22, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED DURING A TRANSURETHRAL LITHOTOMY (TUL) PROCEDURE, THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR WOULD NOT OPEN/CLOSE AT THE TARGET SITE. SO ITS USE WAS DISCONTINUED. ANOTHER 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. 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 21885341 ↗MalfunctionApr 22, 2025Difficult to Open or Close; Difficult to Open or Close
ADDITIONAL INFORMATION RECEIVED ON 12MAY2025: DISTRIBUTOR PROVIDED THE INFORMATION: USER FACILITY REPORTED THE USER OPENED THE PACKAGE AND TESTED THE DEVICE BUT FOUND OUT THE BASKET CANNOT BE OPENED. NURSE DISCARDED THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21884581 ↗MalfunctionApr 18, 2025Break; Break
IT WAS REPORTED, DURING A RETROGRADE INTRARENAL SURGERY (RIRS) TO REMOVE A STONE LOCATED IN THE RIGHT KIDNEY; THE THREAD OF THE NGAGE NITINOL STONE EXTRACTOR BASKET PRONG BROKE. ITS USE WAS DISCONTINUED, AND THE PHYSICIAN COMPLETED THE PROCEDURE USING ANOTHER SAME TYPE DEVICE. 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 21867959 ↗MalfunctionApr 17, 2025Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21857133 ↗MalfunctionApr 4, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED AFTER THE DOCTOR OPENED THE PACKAGE, PRIOR TO BEING USED, AND CHECKED THE NGAGE NITINOL STONE EXTRACTOR, HE FOUND THE BASKET COULD NOT BE OPENED WHEN HE PULLED THE HANDLE. THE PROCEDURE WAS COMPLETED USING A SAME TYPE DEVICE. 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 21773631 ↗MalfunctionApr 1, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR¿S BASKET WAS UNABLE TO OPEN UPON THE SECOND ATTEMPT TO GRASP A STONE DURING FIBEROPTIC TRANSURETHRAL LITHOTRIPSY (F-TUL) IN THE RENAL CALYX. THE DEVICE WAS INSERTED VIA THE FORCEPS' PORT OF A FLEXIBLE URETEROSCOPE TO CONDUCT STONE EXTRACTION WHEN THE ISSUE WAS FOUND. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE COMPLAINT DEVICE WAS INSPECTED PRIOR TO USE TO ENSURE NO DAMAGE HAD OCCURRED. THE BASKET WAS TESTED IN AN UNCOILED POSITION PRIOR TO USE AND WAS FOUND TO BE FUNCTIONING PROPERLY. A LASER WAS USED DURING THE PROCEDURE. NO PART OF THE DEVICE SEPARATED IN THE PATIENT. THERE WAS NOTHING OF NOTE CONCERNING THE PATIENT¿S ANATOMY KEEPING THE BASKET FROM OPENING OR CLOSING. 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 21742849 ↗MalfunctionMar 27, 2025Break; Break
IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR¿S BASKET WIRE WAS BROKEN WHEN THE PACKAGE WAS OPENED, PRIOR TO AN UNSPECIFIED PROCEDURE. 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. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21707657 ↗MalfunctionMar 24, 2025Difficult to Open or Close; Material Split, Cut or Torn; Difficult to Open or Close; Material Split, Cut or Torn
IT WAS INITIALLY REPORTED THE DEVICE DID NOT OPEN AND CLOSE PROPERLY. THE DEVICE WAS RETURNED AND FOUND A WIRE WAS PULLED FROM THE SHEATH AND THE SHEATH WAS DAMAGED IN MULTIPLE PLACES INCLUDING ONE BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21684203 ↗MalfunctionMar 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED, DURING A URETERAL CALCULI STONE REMOVAL PROCEDURE, THE USER DETECTED THE HANDLE STUCK AND THE TIP DAMAGED IN A NGAGE NITINOL STONE EXTRACTOR. SO, ITS USE WAS DISCONTINUED. THE USER CHANGED TO A NEW SAME TYPE DEVICE 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. 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 21530011 ↗MalfunctionMar 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21527267 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS REPORTED THAT THE BASKET OF 'NGAGE NITINOL STONE EXTRACTOR' BROKE DURING AN UNSPECIFIED PROCEDURE. THE BASKET HAD BEEN OPENED ONCE AND USED TO REMOVE A STONE. THEN IT BROKE AND WOULD NOT CLOSE. AS REPORTED, THE BASKET STOPPED WORKING OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER BASKET. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21413771 ↗MalfunctionApr 28, 2020Difficult to Open or Close
MALFUNCTION - DOESN'T CLOSE ALL THE WAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10004728 ↗MalfunctionDec 19, 2019Unsealed Device Packaging; Unsealed Device Packaging
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9497240 ↗MalfunctionDec 19, 2019Difficult to Open or Close; Difficult to Open or Close
ADDITIONAL INFORMATION WAS RECEIVED ON 02JAN2020: A NEW NGAGE BASKET DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9496897 ↗MalfunctionDec 11, 2019Difficult to Open or Close; Difficult to Open or Close
ADDITIONAL INFORMATION WAS RECEIVED ON 17DEC2019: THE PHYSICIAN CONFIRMED THE BASKET COULD NOT BE FULLY OPENED PRIOR TO USE, BUT HE ATTEMPTED TO USE IT DURING THE PROCEDURE. HE TRIED SEVERAL TIMES TO COLLECT STONES BUT WAS UNSUCCESSFUL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9451398 ↗MalfunctionDec 9, 2019Difficult to Open or Close; Difficult to Open or Close
NO ADDITIONAL PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9438543 ↗MalfunctionNov 14, 2019Break; Break
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 14NOV2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9323806 ↗MalfunctionNov 11, 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 ON 11NOV2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9305776 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
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- NCircle G46206Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL197 reports
- NCircle G17520Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL129 reports
- NGage G48297Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL96 reports
- NCircle G19110Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL88 reports
- Bard® SkyLite™ Tipless Nitinol Stone Basket 041900C. R. Bard, Inc. · DISLODGER, STONE, BASKET, URETERAL, METAL78 reports
- NGage G48295Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL74 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.