NGage G48296Recalls & reported problems
Cook Incorporated · NGage Nitinol Stone Extractor Modified Basket · Class 2
Quick summary
This Cook NGage nitinol stone extractor is a wire basket used to remove stones from the kidney or ureter during surgery. Most of the 73 reports describe the basket failing to open or close, or the wire snapping or separating, sometimes before the procedure begins; in the cases described, no fragments were left in the patient. Reports run from 2017 to 2025, with no deaths, no injuries, and no recalls naming this device.
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
- 73
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00827002482968), received between Feb 28, 2017 and Jul 29, 2025 — classified as 73 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
- Device Operates Differently Than Expected12
- Break10
- Material Separation3
- Device Damaged Prior to Use2
- Mechanical Problem2
- Bent1
- Coiled1
Patient problems
- No Consequences Or Impact To Patient44
- No Known Impact Or Consequence To Patient16
- No Patient Involvement9
- No Clinical Signs, Symptoms or Conditions7
- No Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT THE BASKET WIRE ON A NGAGE NITINOL STONE EXTRACTOR SNAPPED DURING USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF AN UNKNOWN IDENTITY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 22647101 ↗MalfunctionJun 16, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR¿S BASKET WAS UNABLE TO OPEN DURING AN UNSPECIFIED PROCEDURE. THE ISSUE WAS FOUND WHEN THE BASKET WAS UNCOVERED FOR USE AND TESTING THE ACTION MECHANISM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. 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 22214495 ↗MalfunctionJun 5, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED PRIOR TO PATIENT CONTACT, AFTER OPENING, THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR WAS TESTED AND DID NOT OPEN. ANOTHER BASKET WAS REQUESTED TO COMPLETE THE UNKNOWN PROCEDURE. NO UNINTENDED SECTION OF THIS DEVICE REMAINS INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22152281 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR¿S BASKET WIRE BROKE DURING A BILATERAL RETROGRADE INTRARENAL SURGERY (RIRS) TO REMOVE A STONE FRAGMENT. 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 22144040 ↗MalfunctionJun 3, 2025Break; Break
IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR¿S BASKET WIRE WAS BROKEN PRIOR TO USE IN THE RETROGRADE INTRARENAL SURGERY (RIRS). THE ISSUE WAS FOUND WHEN THE USER OPENED THE DEVICE. THE PHYSICIAN PROCEEDED WITH THE PROCEDURE AND SUCCESSFULLY COMPLETED THE SURGERY BY FRAGMENTING THE STONE. THE DEVICE DID NOT MAKE PATIENT CONTACT. A CUSTOMER PROVIDED PICTURE APPEARS TO SHOW A BROKEN BASKET WIRE. 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 22132689 ↗MalfunctionFeb 7, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334901 ↗MalfunctionFeb 7, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334289 ↗MalfunctionOct 1, 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 01OCT2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9139573 ↗MalfunctionSep 30, 2019Difficult to Open or Close; Difficult to Open or Close
ADDITIONAL INFORMATION RECEIVED ON 01OCT2019: THE PROCEDURE WAS COMPLETED BY USING ANOTHER NGAGE NITINOL STONE EXTRACTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9136444 ↗MalfunctionSep 18, 2019Difficult to Open or Close; Difficult to Open or Close
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9082620 ↗MalfunctionSep 18, 2019Difficult to Open or Close; Difficult to Open or Close
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9082000 ↗MalfunctionSep 12, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9008249 ↗MalfunctionAug 15, 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 15AUG2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8896368 ↗MalfunctionJul 23, 2019Difficult to Open or Close; Difficult to Open or Close
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8816210 ↗MalfunctionJun 27, 2019Difficult to Open or Close; Difficult to Open or Close
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8742381 ↗MalfunctionMay 24, 2019Device Damaged Prior to Use; Device Damaged Prior to Use
ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8641358 ↗MalfunctionApr 12, 2019Break; 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 8511832 ↗MalfunctionJan 21, 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 8265040 ↗MalfunctionDec 7, 2018Break; Break
THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8142907 ↗MalfunctionNov 26, 2018Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, WHILE PREPARING FOR A FLEXIBLE URETEROSCOPY (URS), THE NGAGE NITINOL STONE EXTRACTOR WAS OPENED, THEY TESTED THE DEVICE AND DISCOVERED THE BASKET WOULD NOT OPEN. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8102105 ↗MalfunctionNov 15, 2018Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, BEFORE THE PROCEDURE, THE EXTRACTOR CAN'T BE OPENED WHEN THE PHYSICIAN TESTED THE PRODUCT. THEREFORE, THEY CHANGED TO THE NEW ONE AND IT CAN BE OPENED. NO ADVERSE CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8074678 ↗MalfunctionNov 1, 2018Break; Break
IT WAS REPORTED, DURING A STONE EXTRACTION PROCEDURE, THE NGAGE NITINOL STONE EXTRACTOR WAS "BROKEN" BEFORE USE. THE DEVICE WAS OPENED WHEN THE PATIENT WAS ON THE TABLE, THEY CHECKED THE DEVICE BEFORE USE, AND FOUND IT TO BE "BROKEN", SO THEY DID NOT USE IT. THE DEVICE WAS TAKEN OFF THE "FIELD" AND ANOTHER OPENED. THE CUSTOMER SENT A PICTURE OF THE DEVICE AND IT APPEARS THE YELLOW SHEATH IS DETACHED WHERE IT GOES INTO THE HANDLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8028807 ↗MalfunctionSep 21, 2018Difficult to Open or Close; Difficult to Open or Close
THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7899318 ↗MalfunctionSep 14, 2018Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close
IT WAS REPORTED DURING A URETEROSCOPY WITH LITHOTRIPSY, TWO NGAGE NITINOL STONE EXTRACTORS WEREN¿T CLOSING PROPERLY. UPON FOLLOW UP WITH THE PHYSICIAN FOR ADDITIONAL INFORMATION, THE DOCTOR REPLIED THAT BOTH NGAGE¿S DID NOT FUNCTION PROPERLY. HE USED A COMPETITOR¿S BASKET TO FINISH THE CASE. NO INTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7878259 ↗MalfunctionAug 29, 2018Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED DURING A RETROGRADE INTRARENAL SURGERY (RIRS), THE PHYSICIAN TRIED TO USE THE NGAGE NITINOL STONE EXTRACTOR TO GRAB THE STONE, BUT THEY FOUND THE BASKET CANNOT CLOSE. SO, THEY CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THE PATIENT OUTCOME WAS GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7828387 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
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- NCircle G18778Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL226 reports
- 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
- NGage G48294Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL92 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.