NGageRecalls & reported problems across all models
Cook Incorporated · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 348
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 5 models of NGage by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 348 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2016 and Aug 6, 2025 — classified as 3 injuries, 345 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (198 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NGage problems
Device problems
- Difficult to Open or Close198
- Break64
- Device Operates Differently Than Expected43
- Material Separation12
- Device Damaged Prior to Use8
- Material Split, Cut or Torn7
- Material Deformation6
- Mechanical Problem6
Patient problems
- No Consequences Or Impact To Patient184
- No Known Impact Or Consequence To Patient69
- No Patient Involvement55
- No Clinical Signs, Symptoms or Conditions52
- No Information9
- Insufficient Information3
- Foreign Body In Patient1
- No Code Available1
NGage models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NGage G48297DISLODGER, STONE, BASKET, URETERAL, METAL96 reports
- NGage G48294DISLODGER, STONE, BASKET, URETERAL, METAL92 reports
- NGage G48295DISLODGER, STONE, BASKET, URETERAL, METAL74 reports
- NGage G48296DISLODGER, STONE, BASKET, URETERAL, METAL73 reports
- NGage G23798Laparoscope, general & plastic surgery13 reports
Recent NGage adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionJul 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND IN THE PACKAGE OF A NGAGE NITINOL STONE EXTRACTOR DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE TO REMOVE A URINARY STONE. BEFORE UNPACKING THE DEVICE, THE USER NOTICED THE FOREIGN MATERIAL IN THE PACKAGE AND DID NOT USE THE DEVICE. A SIMILAR-LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 22592080 ↗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 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 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 6, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR WAS UNABLE TO BE CLOSED DURING AN UNSPECIFIED PROCEDURE. THE DEVICE WAS AS ABLE TO OPEN ONCE. 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 22161361 ↗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 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 ↗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, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR WAS UNABLE TO BE CLOSED PRIOR TO AN UNSPECIFIED PROCEDURE. THE DEVICE WAS REMOVED FROM THE PACKAGE AND INSPECTED TO ENSURE THERE WAS NO DAMAGE TO THE DEVICE. THE DEVICE WAS TESTED, AND IT WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE 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 22135889 ↗MalfunctionJun 3, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED PRIOR TO A URETEROSCOPIC STONE REMOVAL PROCEDURE, THE USER OPENED THE PACKAGE AND CHECKED THE DEVICE AND FOUND THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR COULD NOT BE OPENED OR CLOSED COMPLETELY. 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 22135594 ↗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 ↗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 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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