Super Sheath CBDE (CBDE) CI12L25TP0038Recalls & reported problems
Togo Medikit CO.,Ltd. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04543527251952), received between Dec 30, 2021 and Dec 30, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2021Detachment of Device or Device Component; Material Deformation; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Material Deformation; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUPER SHEATH CBDE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SHEATH KINKED AND BROKE ABOUT HALFWAY OF THE TOTAL LENGTH. THE PROXIMAL END OF THE SHEATH ATTACHED TO THE HUB WAS IMMEDIATELY REMOVED AND THE OTHER PIECE WAS REMOVED USING A LAPAROSCOPIC GRASPER THROUGH ONE OF THE PORTS USED DURING THE LAPAROSCOPIC CHOLECYSTECTOMY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13118378 ↗
Other CATHETER, PERITONEAL devices
- ARROW IPN036986Teleflex Incorporated · CATHETER, PERITONEAL2 recalls0 reports
- CARDINAL HEALTH 30414-025Cardinal Health 200, LLC · CATHETER, PERITONEAL2 reports
- ARROW IPN032635Teleflex Incorporated · CATHETER, PERITONEAL2 reports
- Tenckhoff G09085Cook Incorporated · CATHETER, PERITONEAL1 report
- Cook G05262Cook Incorporated · CATHETER, PERITONEAL1 report
- Cook G05267Cook Incorporated · CATHETER, PERITONEAL1 report
- Medline DYND50428Medline Industries, Inc. · CATHETER, PERITONEAL1 report
- Cook G09269Cook Incorporated · CATHETER, PERITONEAL1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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