NCompassRecalls & 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
1 open recall names at least one NCompass model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 5 models of NCompass by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Feb 27, 2017 and Sep 29, 2026 — classified as 1 injury, 68 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (34 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
NCompass recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1787-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Most reported NCompass problems
Device problems
- Difficult to Open or Close34
- Break26
- Material Separation11
- Device Operates Differently Than Expected4
- Fracture2
- Component Missing1
- Contamination /Decontamination Problem1
- Deformation Due to Compressive Stress1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient21
- No Known Impact Or Consequence To Patient10
- No Patient Involvement5
- Insufficient Information1
NCompass models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NCompass G36251DISLODGER, STONE, BILIARY1 recall8 reports
- NCompass G32701DISLODGER, STONE, BASKET, URETERAL, METAL36 reports
- NCompass G46027DISLODGER, STONE, BASKET, URETERAL, METAL13 reports
- NCompass G32702DISLODGER, STONE, BASKET, URETERAL, METAL9 reports
- NCompass G32863DISLODGER, STONE, BASKET, URETERAL, METAL3 reports
Recent NCompass adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 14, 2026Difficult to Open or Close
Patient problems: Insufficient Information
MAUDE report 50757364 ↗MalfunctionAug 4, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132575 ↗MalfunctionApr 20, 2026Break; Difficult to Open or Close
IT WAS REPORTED THAT THE HANDLE OF A N-COMPASS NITINOL STONE EXTRACTOR BROKE. THE SURGEON PERFORMED A DUCTOTOMY OF THE CYSTIC DUCT AND SUCCESSFULLY COMPLETED A CHOLANGIOGRAM USING A 5 FR CHOLANGIO CATHETER. MULTIPLE STONES WERE IDENTIFIED AND CLEARED FROM THE CYSTIC DUCT; HOWEVER, THE CHOLANGIOGRAM REVEALED AN ADDITIONAL STONE IN THE COMMON BILE DUCT. THE SURGEON ELECTED TO PROCEED WITH A COMMON DUCT EXPLORATION TO REMOVE THE STONE. A WIRE GUIDE WAS ADVANCED THROUGH THE CHOLANGIO CATHETER, AFTER WHICH THE CHOLANGIO CATHETER WAS REMOVED. A 6 MM BILIARY BALLOON CATHETER WAS THEN ADVANCED INTO THE DUCTOTOMY OVER THE WIRE GUIDE. DILATION WAS PERFORMED USING A SPHERE INFLATION DEVICE WITH A 50% CONTRAST MEDIUM AND 50% SALINE SOLUTION. A SUCCESSFUL DILATION WAS ACHIEVED FOLLOWING THE PRESCRIBED 5-MINUTE DILATION PERIOD. THE BALLOON CATHETER WAS REMOVED, LEAVING THE WIRE GUIDE IN PLACE, AND A CHOLANGIOSCOPE WAS ADVANCED OVER THE WIRE GUIDE. THE WIRE GUIDE WAS THEN REMOVED, AND THE N-COMPASS BASKET WAS ADVANCED INTO THE CYSTIC DUCT. THE STONE WAS VISUALIZED; HOWEVER, THE RESOLUTION OF THE SCOPE IMAGE WAS NOTED TO BE SUBPAR, RESULTING IN A SOMEWHAT BLURRY VIEW. THE STONE WAS LOCATED APPROXI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931719 ↗MalfunctionApr 1, 2026Break; Fracture
AS REPORTED, DURING URETEROSCOPIC STONE REMOVAL PROCEDURE, THE TIP OF THE 'NCOMPASS NITINOL STONE EXTRACTOR' FELL OFF. THE NCOMPASS WAS OPENED AND TESTED PRIOR TO USE WITH NO ISSUES. IT WAS USED TO REMOVE THREE STONE FRAGMENTS. WHEN THE USER ATTEMPTED TO REMOVE THE FOURTH FRAGMENT, THE TIP FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY RETRIEVING THE FRAGMENT AND USING ANOTHER NCOMPASS. 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 24754946 ↗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 ↗MalfunctionFeb 6, 2026Loss of or Failure to Bond; Difficult to Open or Close
IT WAS REPORTED, TWO NCOMPASS NITINOL STONE EXTRACTORS WOULD NOT OPEN AND CLOSE DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THIS REPORT WILL BE FOR DEVICE # 2. REFERENCE PATIENT IDENTIFIER (B)(6) FOR DEVICE # 1. A THIRD SAME TYPE 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 24277902 ↗MalfunctionFeb 6, 2026Break; Difficult to Open or Close
IT WAS REPORTED, TWO NCOMPASS NITINOL STONE EXTRACTORS WOULD NOT OPEN AND CLOSE DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THIS REPORT WILL BE FOR DEVICE # 1. REFERENCE PATIENT IDENTIFIER (B)(6) FOR DEVICE # 2. A THIRD SAME TYPE 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 24277834 ↗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 ↗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 ↗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 ↗MalfunctionSep 9, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED, THE NCOMPASS NITINOL STONE EXTRACTOR WAS STUCK IN THE OPEN POSITION AND WOULD NOT CLOSE, PRIOR TO AN UNSPECIFIED PROCEDURE. THE DEVICE WAS INSPECTED AND THERE WERE NO OBVIOUS DEFECTS. THE ISSUE WAS FOUND WHILE TESTING THE FUNCTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME LIKE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 23003712 ↗
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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