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NForce G17940Recalls & reported problems

Cook Incorporated · NForce, Nitinol Helical Stone Extractor · Class 2

Quick summary

This Cook NForce stone extractor is used to remove stones from the ureter. The 41 reports mostly describe its basket being difficult or unable to open, with occasional deformation, breakage, or material separation; most reports mention no patient impact. The reports include no deaths and 1 injury. No recalls name this device.

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
40
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00827002179400), received between Feb 23, 2017 and Dec 17, 2025 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (33 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: 3 reportsJun 2025: 1 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult to Open or Close33
  • Break2
  • Deformation Due to Compressive Stress2
  • Device Damaged Prior to Use2
  • Device Operates Differently Than Expected2
  • Material Separation2
  • Device Operational Issue1
  • Physical Resistance/Sticking1

Patient problems

  • No Consequences Or Impact To Patient22
  • No Clinical Signs, Symptoms or Conditions9
  • No Known Impact Or Consequence To Patient7
  • No Patient Involvement2
  • No Information1

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 17, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, THREE NFORCE NITINOL HELICAL STONE EXTRACTOR¿S BASKETS WERE UNABLE TO BE OPENED PRIOR TO A PROCEDURE IN THE URETER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23826242 ↗
  • MalfunctionNov 4, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED THE NFORCE NITINOL HELICAL STONE EXTRACTOR WAS UNABLE TO OPEN COMPLETELY DURING A RIGID URETEROLITHOTRIPSY PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE 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 23472506 ↗
  • MalfunctionNov 4, 2025Difficult to Open or Close; Difficult to Open or Close

    THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23469040 ↗
  • MalfunctionJul 22, 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 22563844 ↗
  • MalfunctionJul 21, 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 22555579 ↗
  • MalfunctionJun 9, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE THE BASKET OF AN NFORCE NITINOL HELICAL STONE EXTRACTOR WAS NOT OPENING. THE USER REPLACED THE PRODUCT TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THIS DEVICE REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22168822 ↗
  • MalfunctionMay 28, 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 22099680 ↗
  • MalfunctionMay 12, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, DURING A URETERAL STONE SURGERY IN THE URINARY SYSTEM, THE USER ATTEMPTED TO UTILIZE THE BASKET OF AN NFORCE NITINOL HELICAL STONE EXTRACTOR TO REMOVE URETERAL CALCULI. THE USER ADVANCED THE DEVICE INTO THE ENDOSCOPE WORKING CHANNEL TO CAPTURE THE STONE AND THE BASKET WOULD NOT OPEN (REFENCE THIS REPORT). THE USER THEN CHANGED TO ANOTHER SAME DEVICE REFERENCE (PATIENT IDENTIFIER (B)(6)) AND THE BASKET WOULD NOT OPEN. THE USER CHANGED TO A THIRD SAME DEVICE TO CONTINUE 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 22002807 ↗
  • MalfunctionMay 12, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, DURING A URETERAL STONE SURGERY IN THE URINARY SYSTEM, THE USER ATTEMPTED TO UTILIZE THE BASKET OF AN NFORCE NITINOL HELICAL STONE EXTRACTOR TO REMOVE URETERAL CALCULI. THE USER ADVANCED THE DEVICE INTO THE ENDOSCOPE WORKING CHANNEL TO CAPTURE THE STONE AND THE BASKET WOULD NOT OPEN (REFENCE THIS REPORT). THE USER THEN CHANGED TO ANOTHER SAME DEVICE (REFERENCE PATIENT IDENTIFIER (B)(6)) AND THE BASKET WOULD NOT OPEN. THE USER CHANGED TO A THIRD SAME DEVICE TO CONTINUE 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 22002679 ↗
  • MalfunctionDec 9, 2019Difficult to Open or Close; Difficult to Open or Close

    NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9438345 ↗
  • MalfunctionJul 22, 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 8813128 ↗
  • MalfunctionJun 27, 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 8742277 ↗
  • MalfunctionJun 27, 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 8742242 ↗
  • MalfunctionJun 27, 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 8742158 ↗
  • MalfunctionJun 27, 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 8742119 ↗
  • MalfunctionJun 13, 2019Difficult to Open or Close; Difficult to Open or Close

    ADDITIONAL INFORMATION WAS RECEIVED 27JUN2019: A TOTAL OF THREE DEVICES WERE TESTED PRIOR TO PATIENT CONTACT AND ALL THREE WOULD NOT OPEN AND CLOSE. THE THREE DEVICES WERE FROM THE SAME LOT NUMBER (8974858). THE PROCEDURE WAS COMPLETED WITH A COMPETITORS' DEVICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8698427 ↗
  • MalfunctionMar 1, 2019Difficult to Open or Close; Difficult to Open or Close

    NO NEW EVENT INFORMATION HAS BEEN RECEIVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8383588 ↗
  • MalfunctionMar 1, 2019Difficult to Open or Close; Difficult to Open or Close

    NO NEW EVENT INFORMATION HAS BEEN PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8383585 ↗
  • MalfunctionFeb 13, 2019Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking

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

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8336253 ↗
  • MalfunctionDec 11, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8152419 ↗
  • MalfunctionNov 9, 2018Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, THE NFORCE NITINOL HELICAL STONE EXTRACTOR WAS TESTED PRIOR TO A URETEROLITHOTRIPSY PROCEDURE AND IT WAS FOUND THAT THE EXTRACTOR DID NOT WORK. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8055359 ↗
  • MalfunctionOct 31, 2018Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, DURING A URETEROLITHOTRIPSY PROCEDURE, AFTER THE DOCTOR BROKE THE STONE, HE INTRODUCED THE NFORCE NITINOL HELICAL STONE EXTRACTOR AND REMOVED SOME FRAGMENTS. WHEN HE RE-INTRODUCED THE EXTRACTOR, THE BASKET DID NOT CLOSE. ANOTHER EXTRACTOR WAS OPENED TO FINISH THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8025523 ↗
  • MalfunctionJul 25, 2018Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, PRIOR TO BEGINNING URETER LITHOTRIPSY, THE BASKET OF THE NFORCE NITINOL HELICAL STONE EXTRACTOR DID NOT OPEN. ANOTHER EXTRACTOR WAS OPENED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7718360 ↗
  • MalfunctionJul 12, 2018Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED AN NFORCE NITINOL HELICAL STONE EXTRACTOR WAS USED DURING A NEPHROLITHOTRIPSY PROCEDURE. AS REPORTED, THE BASKET OPENED AND CLOSED ONCE, THEN IT DIDN'T OPEN ANYMORE. A NEW NFORCE NITINOL HELICAL STONE EXTRACTOR WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT OR ADVERSE CONSEQUENCE TO THE PATIENT DUE TO THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7681396 ↗
  • MalfunctionJul 3, 2018Break; Break

    IT WAS REPORTED, DURING A URETEROLITHOTRIPSY PROCEDURE THE BASKET OF THE NFORCE NITINOL HELICAL STONE EXTRACTOR DID NOT OPEN OR CLOSE. AS REPORTED, THE HANDLE WAS REMOVED, SEPARATED FROM THE EXTRACTOR BODY. A NEW EXTRACTOR WAS OPENED TO CONCLUDE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7659887 ↗

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.