NCompass G32863Recalls & reported problems
Cook Incorporated · NCompass, Nitinol Stone Extractor 4 Wire Basket 1.5cm · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002328631), received between Mar 22, 2018 and Sep 14, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (2 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 Close2
- Break1
Patient problems
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Difficult to Open or Close
Patient problems: Insufficient Information
MAUDE report 50757364 ↗MalfunctionJul 3, 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 8760136 ↗MalfunctionMar 22, 2018Break; Break
IT WAS REPORTED THE NCOMPASS NITINOL TIPLESS STONE EXTRACTOR BASKET PROBE BROKE DURING USE IN A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. BUT DID NOT SEPARATE FROM THE DEVICE WHEN THE FACILITY WAS TRYING TO USE IT ON A STONE. A NEW STONE EXTRACTOR WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE IFU CLEARLY STATES THE NCOMPASS NITINOL TIPLESS STONE EXTRACTOR IS INTENDED FOR STONE MANIPULATION AND REMOVAL IN THE URINARY TRACT. NO UNINTENDED SECTION OF THE DEVICE FELL INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED. THERE WERE NO ADVERSE CONSEQUENCES OR EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7361029 ↗
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.