Fanelli G12950Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002129504), received between Jul 19, 2017 and Oct 4, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2017Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING AND SALINE WAS INJECTED INTO THE SALINE PORT FOR THE FIRST TIME, A LEAK WAS OBSERVED. THE SOURCE WAS REPORTEDLY A CRACK IN THE 3 WAY TAP OF THE DEVICE. A SECOND DEVICE WAS OPENED TO CONTINUE THE PROCEDURE WITH NO FURTHER COMPLICATIONS REPORTED. THE CUSTOMER CONFIRMED THAT THERE WERE NO ADVERSE PATIENT OUTCOMES. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE EVENT OCCURRED DURING A COMMON BILE DUCT EXPLORATION DURING CHOLECYSTECTOMY. PHOTOS, OPERATING REPORTS, X-RAYS, AND SCANS WERE REQUESTED. THE REPORTER INDICATED THAT SUCH WILL NOT BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6914644 ↗
• MalfunctionJul 19, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CUSTOMER REPORTED OBSERVING FOREIGN MATTER DESCRIBED AS A HAIR WITHIN AN UNOPENED PACKAGE OF A FANELLI CHOLANGIOGRAPHY CATHETER SET. THERE WAS NO PATIENT CONTACT; ACCORDINGLY NO ADVERSE PATIENT CONSEQUENCE. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6725146 ↗