Perc NCircleRecalls & reported problems across all models
Cook Incorporated · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of Perc NCircle by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2016 and Apr 8, 2026 — classified as 1 injury, 33 malfunctions.
The most frequently reported specific device problem is “Break” (9 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. 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
Most reported Perc NCircle problems
Device problems
- Break9
- Difficult to Open or Close7
- Material Twisted/Bent6
- Device Contaminated During Manufacture or Shipping5
- Tear, Rip or Hole in Device Packaging3
- Detachment of Device or Device Component2
- Material Separation2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient5
- No Patient Involvement3
- No Code Available1
- No Information1
Perc NCircle models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Perc NCircle G32862DISLODGER, STONE, BASKET, URETERAL, METAL24 reports
- Perc NCircle G27234DISLODGER, STONE, BASKET, URETERAL, METAL10 reports
Recent Perc NCircle adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT FLAKES OF A FOREIGN MATERIAL SUBSTANCE WERE INSIDE THE UNOPENED STERILE PACKAGING OF A PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR. A PRELIMINARY INVESTIGATION OF THE RETURN DEVICE SHOWS THERE WAS FOREIGN MATTER INSIDE THE SEALED PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815649 ↗MalfunctionMar 13, 2026Detachment of Device or Device Component
IT WAS REPORTED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR, WAS BROKEN AT THE JUNCTION WHERE THE SHAFT CONNECTS TO THE RED HANDLE. THE SHAFT WAS DISCONNECTED FROM THE HANDLE BUT NOT DETACHED. THE SURGEON ATTEMPTED TO RECONNECT THE DEVICE AND PROCEEDED WITH ITS USE. AFTER INSERTION INTO THE PATIENT, THE DEVICE FAILED TO OPEN/DEPLOY AND WAS UNABLE TO GRASP THE STONE. AS SUCH, THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME TYPE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. MOREOVER, AS REPORTED, THE PATIENT DID NOT HAVE TORTUOUS, CALCIFIED, OR SCARRED ANATOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24595556 ↗MalfunctionJan 12, 2026Material Twisted/Bent
ADDITIONAL INFORMATION WAS RECEIVED ON 02MAR2026. THE USER NOTICED THE BASKET WAS BENT WHEN THEY TOOK IT OUT OF THE PACKAGE. THEREFORE, THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER BASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037415 ↗MalfunctionOct 20, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL), THE BASKET OF THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR "BROKE" WHEN EXTRACTING A STONE. THE BASKET "BROKE" WHILE THE PHYSICIAN WAS FORCEFULLY PULLING THE STONE THROUGH THE ACCESS SHEATH. THE PATIENT HAD SEVERAL LARGE STONES, BUT THE SIZE OF THE STONE BEING REMOVED IS UNKNOWN. A PHOTO WAS PROVIDED THAT APPEARS TO SHOW THE BASKET WIRES SEPARATED FROM THE BASKET CANNULA. A SECOND NCIRCLE EXTRACTOR WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, NO SECTION OF THE DEVICE REMAINED 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 23334693 ↗MalfunctionOct 10, 2025Difficult to Open or Close; Difficult to Open or Close
CORRECTION: THREE EXTRACTORS WERE NOT ABLE TO OPEN AND CLOSE DURING THE SAME PROCEDURE FOR THE SAME PATIENT. ONE OF THE EXTRACTORS IS COVERED UNDER THIS REPORT WITH THE PATIENT IDENTIFIER 091076 AND MANUFACTURER REPORT NUMBER 1820334-2025-01229. THE OTHER TWO EXTRACTORS ARE COVERED UNDER THE MANUFACTURER REPORT NUMBER 1820334-2025-01224 AND 1820334-2025-01227. ADDITIONAL INFORMATION WAS RECEIVED 16DEC2025. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER EXTRACTOR THAT WAS FUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23270268 ↗MalfunctionOct 10, 2025Difficult to Open or Close; Difficult to Open or Close
CORRECTION: THREE EXTRACTORS WERE NOT ABLE TO OPEN AND CLOSE DURING THE SAME PROCEDURE FOR THE SAME PATIENT. ONE OF THE EXTRACTORS IS COVERED UNDER THIS REPORT WITH THE PATIENT IDENTIFIER: (B)(6) AND MANUFACTURER REPORT NUMBER: 1820334-2025-01224. THE OTHER TWO EXTRACTORS ARE COVERED UNDER THE MANUFACTURER REPORT NUMBER: 1820334-2025-01229 AND 1820334-2025-01227. ADDITIONAL INFORMATION WAS RECEIVED 16DEC2025. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER EXTRACTOR THAT WAS FUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23270191 ↗MalfunctionAug 15, 2025Difficult to Open or Close; Difficult to Open or Close
AS REPORTED, TWO PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR'S EXHIBITED STICKING ISSUES WITH THE GRASPER HANDLES WHEN THE USER ATTEMPTED TO GRASP THEM WITHIN AN UNSPECIFIED SCOPE. THE ISSUE WAS IDENTIFIED DURING THE UNSPECIFIED PROCEDURE. THE PHYSICIAN OPENED A NEW PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR DEVICE AND SUCCESSFULLY COMPLETED THE CASE. 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 22819374 ↗MalfunctionJun 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 22232930 ↗MalfunctionMay 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 22036675 ↗MalfunctionMar 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY THE DISTRIBUTOR, THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR HAS SOME WHITE BUBBLES INSIDE THE PACKAGING. THE DEVICE WAS STORED IN DISTRIBUTOR´S WAREHOUSE, THE STORAGE CONDITIONS ARE REGULATED BY NOM-241-SSA1-2012, AT 52 HUMIDITY, 21CELSIUS DEGREES. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT. THE CUSTOMER ATTACHED IMAGES OF WHAT APPEARS TO SHOW FOREIGN MATTER - WHITE BUBBLES, INSIDE THE PACKAGE. PATIENT WAS NOT INVOLVED. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21505252 ↗MalfunctionFeb 20, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED A PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR¿S PACKAGE CONTAINED FOREIGN MATTER ¿DEBRIS." THE ISSUE WAS FOUND PRIOR TO OPENING THE PACKAGE ON DELIVERY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. REPORTEDLY, THE DEVICES ARE KEPT IN AN OUTWARDS AREA WHICH IS AN AIR CONDITIONED AND CONTROLLED ENVIRONMENT. A PHOTO PROVIDED SHOWED BROWN RUST-LIKE MATERIAL IN THE PACKAGE. 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 21421761 ↗MalfunctionMar 29, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, A DARK STAIN IN THE ROD NEAR THE PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR'S HANDLE WAS IDENTIFIED DURING THE PROCESS OF RECEIVING AND CHECKING PRODUCTS AT THE DISTRIBUTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19008149 ↗MalfunctionNov 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
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 18069715 ↗MalfunctionMar 25, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THE PACKAGING OF A PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR WAS PERFORATED. THIS WAS NOTED UPON RECEIVING THE DEVICE AND PRIOR TO PATIENT USE OR CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13904706 ↗MalfunctionAug 11, 2021Break; 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 12308944 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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