NGage G48295Recalls & reported problems
Cook Incorporated · NGage, Nitinol Stone Extractor Modified Basket · Class 2
All models of NGage (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cook NGage nitinol stone extractor basket is used to grab and remove kidney or ureteral stones. The reports mostly describe baskets that would not open or close properly, plus broken or damaged wires and tips, and material found inside the packaging. There are 74 reports, with no deaths and no injuries; in most of them the device was swapped out and no patient harm followed. No recalls name this device. Reports have dropped off sharply, from 14 in the previous 12 months to none in the last 12 months.
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
- 74
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00827002482951), received between Mar 8, 2017 and Jul 24, 2025 — classified as 74 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (44 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close44
- Break14
- Device Operates Differently Than Expected4
- Detachment Of Device Component3
- Material Separation3
- Defective Device2
- Crack1
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient38
- No Patient Involvement15
- No Clinical Signs, Symptoms or Conditions14
- No Known Impact Or Consequence To Patient9
- Insufficient Information1
- No Information1
Recent adverse event reports
The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.
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 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 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 ↗MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THE FRONT END OF A NGAGE NITINOL STONE EXTRACTOR´S BASKET WAS FOUND BROKEN PRIOR TO USE IN AN UNSPECIFIED PROCEDURE. THE ISSUE WAS FOUND WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061154 ↗MalfunctionMay 14, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED NGAGE NITINOL STONE EXTRACTOR´S BASKET WAS FOUND TO BE DAMAGED PRIOR TO AN UNSPECIFIED PROCEDURE. THE ISSUE WAS FOUND WHEN THE BASKET WAS OPENED. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 22018572 ↗MalfunctionMay 12, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED DURING A TRANSURETHRAL LITHOTOMY (TUL), THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR WAS UNABLE TO OPEN. THE PROCEDURE WAS COMPLETED BY ANOTHER SAME-LIKE DEVICE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002452 ↗MalfunctionMay 9, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THE BLACK PART OF THE HANDLE OF AN NGAGE NITINOL STONE EXTRACTOR WAS DIFFICULT TO OPERATE DURING A TRANSURETHRAL URINARY STONE REMOVAL PROCEDURE. THE ISSUE WAS FOUND WHEN THE DEVICE WAS INSERTED IN THE BODY, AND IT WAS DESCRIBED AS BEING HEAVY, NOT SMOOTH AND VERY DIFFICULT TO USE. 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 21993325 ↗MalfunctionMar 27, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE NGAGE NITINOL STONE EXTRACTOR WAS FOUND TO BE FAULTY, AS IT WAS NOT CLOSING FULLY, ITS USE WAS DISCONTINUED. THE SURGEON OPTED TO USE A BACKUP DEVICE INSTEAD 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 21715422 ↗MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR¿S LOWER PART OF THE BASKET WAS NOTED TO BE BROKEN DURING A LITHOTRIPSY PROCEDURE FOR REMOVAL OF A KIDNEY STONE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A CUSTOMER PROVIDED PICTURE APPEARS TO SHOW SEPARATION OF THE BASKET FROM THE BASKET SHEATH. 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 21700976 ↗MalfunctionMar 25, 2025Break; Break
IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THE USER DETECTED THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR WAS BROKEN IN THE CONNECTION PLACE. WHEN ENTERING THE BODY, THE FRACTURE CANNOT GRASP THE STONE DURING THE OPERATION. USE OF THE DEVICE WAS DISCONTINUED AND 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 21693975 ↗MalfunctionMar 11, 2025Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED ON 13MAR2025. TYPE OF PROCEDURE WAS A UTEROSCOPY. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21574427 ↗MalfunctionMar 5, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, THE USER PUSHED THE HANDLE OF A NGAGE NITINOL STONE EXTRACTOR, BUT FOUND OUT THE BASKET COULD NOT OPEN WHILE ADVANCING INTO THE PATIENT. USE OF THE DEVICE WAS DISCONTINUED. THE USER CHANGED TO A NEW SAME TYPE DEVICE 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 21530923 ↗MalfunctionFeb 19, 2025Difficult to Open or Close; Difficult to Open or Close
CORRECTION: IT WAS REPORTED THAT THE BASKETS OF TWO (2) 'NGAGE NITINOL STONE EXTRACTORS' COULD NOT BE OPENED PRIOR TO AN UNSPECIFIED RENAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411887 ↗MalfunctionDec 9, 2019Difficult to Open or Close; Difficult to Open or Close
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9438941 ↗MalfunctionNov 26, 2019Difficult to Open or Close; Difficult to Open or Close
NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9375815 ↗MalfunctionNov 21, 2019Difficult to Open or Close; Difficult to Open or Close
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9354336 ↗MalfunctionNov 12, 2019Difficult to Open or Close; Difficult to Open or Close
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON 12NOV2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9310401 ↗MalfunctionNov 4, 2019Difficult to Open or Close; Difficult to Open or Close
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9271793 ↗MalfunctionOct 29, 2019Break; Break
NO NEW PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 29OCT2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9250157 ↗MalfunctionOct 17, 2019Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE A NGAGE NITINOL STONE EXTRACTOR WAS TESTED, AND IT WAS DISCOVERED THAT IT COULD NOT BE CLOSED AFTER IT WAS OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEW DEVICE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE INCLUDED IN A FOLLOW-UP REPORT WHEN AND IF THAT INFORMATION IS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9203270 ↗MalfunctionOct 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON 15OCT2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9192464 ↗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 9174559 ↗MalfunctionSep 30, 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 30SEP2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9134034 ↗MalfunctionJul 16, 2019Material Deformation; Material Deformation
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8796411 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
- Zero Tip M0063901050Boston Scientific Corporation · DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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