NCompass G46027Recalls & reported problems
Cook Incorporated · NCompass, Nitinol Stone Extractor 4 Wire Basket · Class 2
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002460270), received between Mar 28, 2018 and Sep 29, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Difficult to Open or Close5
- Device Operates Differently Than Expected2
- Difficult or Delayed Positioning1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient8
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939105 ↗MalfunctionNov 3, 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 23458017 ↗MalfunctionNov 20, 2019Break; Break
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED SINCE THE LAST REPORT WAS SENT ON (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9348279 ↗MalfunctionNov 7, 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 9289484 ↗MalfunctionOct 9, 2019Difficult to Open or Close; Difficult to Open or Close
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON 09OCT2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9172805 ↗MalfunctionOct 1, 2019Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 01OCT2019: A NEW SAME TYPE DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9140094 ↗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 Patient Involvement
MAUDE report 9135656 ↗MalfunctionMay 1, 2019Difficult 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 Consequences Or Impact To Patient
MAUDE report 8570277 ↗MalfunctionFeb 22, 2019Break; Break
IT WAS REPORTED DURING A URETEROSCOPY WITH STONE REMOVAL PROCEDURE, TWO NCOMPASS NITINOL TIPLESS STONE EXTRACTOR BASKETS BROKE. DR. SAID THE DISTAL END WITH THE ¿STICK¿ IS MORE FLIMSY THAN ANOTHER MANUFACTURER'S ONE AND THAT HE IS MORE CAREFUL WHILE USING THIS PRODUCT. NO UNINTENDED PART OF THE DEVICE WAS LEFT INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THESE OCCURRENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8363299 ↗MalfunctionFeb 20, 2019Break; Material Separation; Break; Material Separation
IT WAS INITIALLY REPORTED THE DEVICES BROKE/BENT AT THE ORANGE JACKET THAT CONNECTS THE BASKET WIRE TO THE HANDLE DURING USE. THIS HAS CAUSED THE DEVICE TO FAIL AND THE BASKET TO NO LONGER OPEN. ADDITIONAL INFORMATION WAS PROVIDED ON 18-FEB-2019. THIS IS ONE COMPLAINT FOR A QUANTITY OF FOUR (4) NCOMPASS NITINOL TIPLESS STONE EXTRACTORS FROM LOT #9342377. DURING THE URETEROSCOPY W/LASER LITHOTRIPSY PROCEDURE WHILE USING A FLEXIBLE URETEROSCOPE AND A WORKING SHEATH APPROXIMATELY 3.6 FRENCH, THE ORANGE TUBING SHEATH THAT IS BEYOND THE HANDLE BROKE/DISCONNECTED IN ALL INSTANCES. THE DEVICE WAS TESTED PRIOR TO USE. THERE WERE NO ISSUES WITH PATIENT ANATOMY THAT KEPT THE BASKET FROM OPENING/CLOSING. THE DOCTOR USED A 2.2 NCIRCLE BASKET TO FINISH GRABBING THE STONE FRAGMENTS. FURTHER CLARIFICATION WAS RECEIVED ON 20-FEB-2019. NO UNINTENDED PART OF THE DEVICE WAS LEFT INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8355433 ↗MalfunctionMay 9, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND CHECKED THE INTEGRITY OF THE NCOMPASS NITINOL TIPLESS STONE EXTRACTOR AND FOUND THAT THE BASKET CANNOT BE RELEASED. ANOTHER EXTRACTOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7500380 ↗MalfunctionMay 1, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE USER CHECKED THE INTEGRITY OF THE DEVICE AND FOUND THAT THE HANDLE DIDN'T TRIGGER THE BASKET. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7476210 ↗MalfunctionMar 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED DURING PREOPERATIVE TESTING, THE BASKET ON A NCOMPASS NITINOL TIPLESS STONE EXTRACTOR WAS UNABLE TO CLOSE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7378544 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.