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NTrap G32724Recalls & reported problems

Cook Incorporated · NTrap, Stone Entrapment And Extraction Device · Class 2

Quick summary

This Cook Medical NTrap stone removal basket is a wire basket used to capture and remove kidney or ureteral stones during surgery. Reports mostly describe the handle being hard to open, close or adjust, and parts of the basket or its metal rod breaking, sometimes before the procedure even began. 31 reports mention no deaths and no injuries, and no recalls name this device. Reports rose from 3 in the earlier 12 months to 15 in the most recent 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
31
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00827002327245), received between Mar 7, 2017 and Aug 13, 2026 — classified as 31 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 2 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 4 reportsJan 2026: 0 reportsFeb 2026: 6 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 3 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult to Open or Close16
  • Break11
  • Difficult or Delayed Positioning2
  • Appropriate Device Problem Term/Code Not Available1
  • Deformation Due to Compressive Stress1
  • Detachment of Device or Device Component1
  • Device Contaminated During Manufacture or Shipping1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions18
  • No Consequences Or Impact To Patient9
  • No Known Impact Or Consequence To Patient3
  • No Patient Involvement2

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 13, 2026Difficult to Open or Close

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50240501 ↗
  • MalfunctionJun 2, 2026Difficult to Open or Close

    IT WAS REPORTED DURING THE STONE REMOVAL PROCEDURE, ONE TRAP STONE ENTRAPMENT AND EXTRACTION DEVICE WAS "VERY TIGHT AND DIFFICULT TO ADJUST", WHICH AFFECTED THE PROCEDURE WORKFLOW AND RESULTED IN PROLONGED PROCEDURE TIME. THE NTRAP OPERATING HANDLE WAS RETIGHTENED BEFORE THE DEVICE WAS USED DURING 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 25364294 ↗
  • MalfunctionMay 28, 2026Break

    IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, ONE NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE'S OUTER SUPPORT SHEATH OF THE EXTRACTOR BROKE. PER THE SOURCE EMAIL, THE ISSUE WAS DESCRIBED AS A "MESH BASKET BROKEN WIRE". THE DEVICE WAS REPLACED WITH A NEW INSTRUMENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AN IMAGE WAS PROVIDED SHOWING THAT OUTER SUPPORT SHEATH OF THE EXTRACTOR BROKE. 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 25318655 ↗
  • MalfunctionMay 28, 2026Difficult to Open or Close

    IT WAS REPORTED PRIOR TO THE PROCEDURE, ONE NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE WAS TIGHT AND DIFFICULT TO ADJUST. THE OPERATING HANDLE HAS BEEN TIGHTENED BEFORE THE OPERATION. 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 25318590 ↗
  • MalfunctionMay 4, 2026Difficult to Open or Close

    IT HAS BEEN REPORTED, THAT AFTER OPENING THE PACKAGE FOR CLINICAL PRACTICE OF AN NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE IN AN UNSPECIFIED "STONE SURGERY", THE FRONT END OF THE NET BASKET COULD NOT BE EXTENDED NORMALLY USING THE HANDLE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED "NEW BASKET". THERE HAS BEEN NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS OR ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE BASED ON THE INFORMATION AVAILABLE AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25071183 ↗
  • MalfunctionFeb 19, 2026Break

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE BASKET TIP OF 'NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE' BROKE. AN UNSPECIFIED LASER WAS USED AT THE SAME TIME AS THE BASKET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING WITH ANOTHER NTRAP BASKET. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24393018 ↗
  • MalfunctionFeb 19, 2026Break

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE BASKET TIP OF 'NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE' BROKE. AN UNSPECIFIED LASER WAS USED AT THE SAME TIME AS THE BASKET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING WITH ANOTHER NTRAP BASKET. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24391925 ↗
  • MalfunctionFeb 19, 2026Break; Deformation Due to Compressive Stress

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE FRONT END OF THE "METAL ROD" OF 'NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE' BROKE. AN UNSPECIFIED LASER WAS USED AT THE SAME TIME AS THE BASKET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING WITH ANOTHER NTRAP BASKET. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24390845 ↗
  • MalfunctionFeb 19, 2026Break; Difficult to Open or Close

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE BASKET TIP OF 'NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE' BROKE. AN UNSPECIFIED LASER WAS USED AT THE SAME TIME AS THE BASKET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING WITH ANOTHER NTRAP BASKET. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24390468 ↗
  • MalfunctionFeb 19, 2026Break; Difficult to Open or Close

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE BASKET TIP OF 'NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE' BROKE. AN UNSPECIFIED LASER WAS USED AT THE SAME TIME AS THE BASKET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING WITH ANOTHER NTRAP BASKET. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24390124 ↗
  • MalfunctionFeb 5, 2026Break

    IT WAS REPORTED THAT THE DISTAL END OF THE NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE BROKE DURING USE OF AN UNKNOWN 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 24271992 ↗
  • MalfunctionDec 29, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED THAT THE BASKET TIP OF AN NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE COULD NOT BE RETRACTED PRIOR TO BEING USED IN A PROCEDURE BEING PERFORMED IN THE KIDNEY. THE COMPLAINT DEVICE WAS REPLACED WITH A NEW, SIMILAR-LIKE DEVICE 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 23919347 ↗
  • MalfunctionDec 22, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, DURING AN UNSPECIFIED KIDNEY PROCEDURE, THE USER DETECTED THAT THE BASKET OF AN NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE COULD NOT BE "PUSHED OUT". THE PROCEDURE WAS COMPLETED BY USING AN UNSPECIFIED NEW 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 23864564 ↗
  • MalfunctionDec 18, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE IN THE URETER, THE BASKET TIP OF AN NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE COULD NOT BE PUSHED OUT. A NEW UNSPECIFIED 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 23842952 ↗
  • MalfunctionDec 15, 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 23809596 ↗
  • MalfunctionSep 9, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED THAT THE NTRAP STONE ENTRAPMENT AND EXTRACTION BASKET WOULD NOT OPEN DURING A KIDNEY STONE REMOVAL PROCEDURE ON A MALE PATIENT OF UNSPECIFIED AGE. THE ISSUE WITH THE DEVICE WAS DISCOVERED WHEN THEY TRIED TO OPEN THE BASKET TO REMOVE A STONE. NO STONES WERE ABLE TO BE REMOVED WITH THE DEVICE. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 23008561 ↗
  • MalfunctionAug 20, 2025Break; Break

    IT WAS REPORTED THE NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE¿S BASKET WAS UNABLE TO OPEN AND CLOSE DURING AN URETEROSCOPY PROCEDURE (URS). THE YELLOW SHEATH AT THE HANDLE WAS 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 22857304 ↗
  • MalfunctionAug 20, 2025Break; Break

    IT WAS REPORTED THE NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE¿S BASKET WAS UNABLE TO OPEN AND CLOSE DURING AN URETEROSCOPY PROCEDURE (URS). THE ISSUE WAS FOUND DUE 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 22852299 ↗
  • MalfunctionDec 9, 2019Break; Break

    NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 09DEC2019.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9437733 ↗
  • MalfunctionJun 27, 2019Material Deformation; Material Deformation

    IT IS REPORTED PRIOR TO UNSPECIFIED PROCEDURE USING A NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE, THE USER OPENED THE PACKAGE AND FOUND "THE BASKET SEEMS NOT CORRECT". THIS DEVICE WAS NOT USED. A SECOND BASKET OF THE SAME DEVICE TYPE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8741762 ↗
  • MalfunctionJun 14, 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 8701000 ↗
  • MalfunctionJun 14, 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 8700829 ↗
  • MalfunctionJun 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8698404 ↗
  • MalfunctionMar 21, 2019Mechanical Jam; Mechanical Jam

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8439922 ↗
  • MalfunctionDec 20, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED, THE USER DETECTED THERE IS UNDETERMINED FOREIGN MATTER INSIDE THE STERILIZATION PACKAGE. THE DEVICE WAS NOT USED ON A PATIENT. NO ADVERSE CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8184362 ↗

Other DISLODGER, STONE, BASKET, URETERAL, METAL devices

All DISLODGER, STONE, BASKET, URETERAL, METAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.