NCompass G32701Recalls & reported problems
Cook Incorporated · NCompass, Nitinol Stone Extractor 4 Wire Basket · Class 2
Quick summary
This Cook Medical NCompass nitinol stone extractor is a four-wire basket used to grab and remove kidney and ureter stones. The 37 reports mostly describe the basket sticking open or shut, wires breaking, and the metal separating or twisting, often discovered when staff opened the package before a procedure and then finished the case with another basket. There are no deaths and one injury. No recalls name this device. Reports have slowed, from 17 in the earlier 12 months to 6 in the most recent.
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
- 36
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00827002327016), received between Feb 27, 2017 and Feb 26, 2026 — classified as 1 injury, 35 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (16 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 Close16
- Break14
- Material Separation8
- Contamination /Decontamination Problem1
- Deformation Due to Compressive Stress1
- Device Operates Differently Than Expected1
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient8
- No Known Impact Or Consequence To Patient4
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Difficult to Open or Close
IT WAS REPORTED THE NCOMPASS NITINOL TIPLESS STONE EXTRACTOR¿S BASKET WAS UNABLE TO CLOSE COMPLETELY PRIOR TO USE AN UNSPECIFIED KIDNEY PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. A CUSTOMER ATTACHED A VIDEO APPEARS TO SHOW THE BASKET ONLY PARTIALLY CLOSING AND FULLY OPENING. 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 24454836 ↗MalfunctionFeb 13, 2026Material Separation; Difficult to Open or Close
IT WAS REPORTED THE BASKET OF AN NCOMPASS NITINOL TIPLESS STONE EXTRACTOR WAS UNABLE TO BE OPENED PRIOR TO USE DURING A TRANSURETHRAL LASER LITHOTRIPSY PROCEDURE IN THE URETER/RENAL PELVIS. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. 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 24333217 ↗MalfunctionFeb 13, 2026Difficult to Open or Close
IT WAS REPORTED THE BASKET OF AN NCOMPASS NITINOL TIPLESS STONE EXTRACTOR WAS UNABLE TO BE OPENED PRIOR TO A URETEROSCOPY LITHOTRIPSY PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332569 ↗MalfunctionDec 22, 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 23866986 ↗MalfunctionDec 16, 2025Break; Material Deformation; Break; Material Deformation
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 23818146 ↗MalfunctionOct 21, 2025Difficult to Open or Close; Difficult to Open or Close
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE BASKET OF 'NCOMPASS NITINOL TIPLESS STONE EXTRACTOR' COULD NOT BE OPENED. THE ISSUE WAS DISCOVERED AFTER REMOVING THE OUTER PACKAGING; HENCE THE PRODUCT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER NEW DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352210 ↗MalfunctionAug 29, 2025Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent
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 22927155 ↗MalfunctionAug 29, 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 22927040 ↗MalfunctionAug 18, 2025Material Separation; Difficult to Open or Close; Material Separation; 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 22830635 ↗MalfunctionAug 17, 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 22824457 ↗MalfunctionAug 15, 2025Deformation Due to Compressive Stress; Difficult to Open or Close; Deformation Due to Compressive Stress; 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 22821732 ↗MalfunctionAug 14, 2025Break; Break
IT WAS REPORTED THAT DURING A URETERORENOSCOPY OF THE KIDNEY, THE BASKET OF A NCOMPASS NITINOL TIPLESS STONE EXTRACTOR BROKE. A SECOND NCOMPASS NITINOL TIPLESS STONE EXTRACTOR WAS OPENED AND THE BASKET BROKE IN HALF (COVERED UNDER PATIENT IDENTIFIER (B)(6). THE PROCEDURE WAS COMPLETED WITHOUT A BASKET DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NO UNINTENDED SECTION OF THE DEVICE THAT REMAINED INSIDE THE PATIENT¿S BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808946 ↗MalfunctionAug 14, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED 14APR2026. AN UNSPECIFIED LASER WAS USED. THERE WERE NO STONE FRAGMENTS LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808913 ↗MalfunctionAug 14, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close
CORRECTION: THE CUSTOMER PROVIDED A PHOTO OF THE NCOMPASS NITINOL TIPLESS STONE EXTRACTOR THAT SHOWED THE BASKET WIRES BROKEN. THE DEVICE WAS RETURNED, AND A PRELIMINARY EVALUATION WAS PERFORMED. A VISUAL EXAMINATION OF THE DEVICE NOTED THE BASKET APPEARED TO BE USED AND ALL 4 BASKET WIRES WERE SEVERED, CHARRED, AND FRAZZLED LOOKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808687 ↗MalfunctionJul 17, 2025Break; Break
IT WAS REPORTED TWO NCOMPASS NITINOL TIPLESS STONE EXTRACTORS WERE BROKEN PRIOR TO USE FOR AN UNSPECIFIED PROCEDURE. THE ISSUE WAS FOUND WHEN THE PACKAGE WAS OPENED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530025 ↗MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED DURING A URETEROSCOPY (URS) URETER PROCEDURE, THE YELLOW SHEATH AND HANDLE OF AN NCOMPASS NITINOL TIPLESS STONE EXTRACTOR WERE SEPARATED SO THE BASKET COULD NOT BE OPENED AND CLOSED. ANOTHER NEW PRODUCT 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 22117630 ↗MalfunctionMay 30, 2025Break; Material Separation; Break; Material Separation
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 22117293 ↗MalfunctionMay 30, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THE NCOMPASS NITINOL TIPLESS STONE EXTRACTOR WAS UNABLE TO OPEN AND CLOSE DURING AN URETEROSCOPY PROCEDURE. REPORTEDLY, THE YELLOW SHEATH AND HANDLE PARTS WERE FOUND TO BE SEPARATED. 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 22117153 ↗MalfunctionMay 29, 2025Break; Break
IT WAS REPORTED DURING AN UNKNOWN PROCEDURE, THE YELLOW SHEATH AND THE HANDLE OF AN NGAGE NITINOL STONE EXTRACTOR WERE SEPARATED, SO THE BASKET COULD NOT BE OPENED AND CLOSED. ANOTHER NEW PRODUCT 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 22107072 ↗MalfunctionMay 28, 2025Fracture; Fracture
IT WAS REPORTED, DURING A STONE EXTRACTION PROCEDURE, THAT THE BASKET WIRE OF A NCOMPASS NITINOL TIPLESS STONE EXTRACTOR SNAPPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095902 ↗MalfunctionMay 28, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED, DURING PREPARATION OF AN NCOMPASS NITINOL TIPLESS STONE EXTRACTOR, THE BASKET WAS UNABLE TO OPEN AND CLOSE DURING AN UNSPECIFIED PROCEDURE. IT WAS FOUND THAT THE YELLOW SHEATH AND HANDLE PARTS WERE SEPARATED. 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 22095111 ↗MalfunctionMay 27, 2025Material Separation; Material Separation
IT WAS REPORTED DURING PREPARATION OF AN NCOMPASS NITINOL TIPLESS STONE EXTRACTOR THE BASKET WAS UNABLE TO OPEN AND CLOSE DURING PRIOR TO AN UNSPECIFIED PROCEDURE. THE YELLOW SHEATH AND HANDLE PARTS WERE SEPARATED. 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 22090236 ↗MalfunctionJul 26, 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 8832914 ↗MalfunctionJun 24, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT IS REPORTED THAT A DISTRIBUTOR FOUND FOREIGN MATTER SEALED INSIDE AN COMPASS NITINOL TIPLESS STONE EXTRACTOR PACKAGE. THE PACKAGE WAS NOT OPENED. THE DEVICE DID NOT MAKE CONTACT WITH ANY PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8727988 ↗MalfunctionMay 14, 2019Break; Break
IT IS REPORTED WHILE PREPARING FOR AN UNSPECIFIED PROCEDURE USING A NCOMPASS NITINOL TIPLESS STONE EXTRACTOR, THE USER OPENED THE PACKAGE AND IT WAS IMMEDIATELY NOTED THE DEVICE WAS BROKEN AND THE BASKET WAS MISSING FROM THE END. THIS DEVICE HAD NO PATIENT CONTACT. A SECOND BASKET WAS OPENED, AND USED TO CARRY ON WITH THE INTENDED PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION. THE CUSTOMER DECLINED TO ANSWER ANY ADDITIONAL QUESTIONS DUE TO THE FACT THAT THE DEVICE MADE NO PATIENT CONTACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8608566 ↗
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.