Captura G32727Recalls & reported problems
Cook Incorporated · Captura, Helical Stone Extractor 4 Wire Basket · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002327276), received between Dec 20, 2017 and Nov 4, 2020 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Difficult to Open or Close1
- Off-Label Use1
- Peeled/Delaminated1
- Unsealed Device Packaging1
Patient problems
- No Known Impact Or Consequence To Patient2
- Internal Organ Perforation1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2020Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED, DURING INSPECTION BY A DISTRIBUTOR, THE PACKAGING OF A CAPTURA HELICAL STONE EXTRACTOR WAS FOUND UNSEALED. THE DEVICE DID NOT MAKE CONTACT WITH A PATIENT AND WAS NOT USED FOR ANY PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 10789396 ↗InjuryJan 23, 2019Off-Label Use; Off-Label Use
THERE IS NO NEW EVENT INFORMATION TO REPORT.
Patient problems: Internal Organ Perforation
MAUDE report 8271042 ↗MalfunctionDec 20, 2017Peeled/Delaminated; Difficult to Open or Close
IT WAS REPORTED THAT THE BASKET WOULD NOT OPEN OR CLOSE. EXAMINATION OF THE DEVICE NOTED THAT THE COATING WAS PEELING OFF FROM THE MIDDLE TO THE DISTAL SHEATH END OF THE BASKET SHEATH. 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 Known Impact Or Consequence To Patient
MAUDE report 7134197 ↗MalfunctionDec 20, 2017Break
IT WAS REPORTED THAT DURING THE PROCEDURE, A PART OF THE BASKET BROKE. VISUAL EXAMINATION OF THE DEVICE SHOWED A BROKEN BASKET FORMATION WIRE. THE PHYSICIAN CHANGED THE PRODUCT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 Known Impact Or Consequence To Patient
MAUDE report 7133113 ↗
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.