Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System PB1860BSXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032036150), received between Apr 21, 2021 and Apr 21, 2021 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2021Crack; Crack

  AS REPORTED, WHEN FLUSHING THE WIRE PORT OF THE .018" 6MM X 18MM X 135CM PALMAZ BLUE ON SLALOM BALLOON-EXPANDABLE STENT DELIVERY SYSTEM (SDS), THE PHYSICIAN SAW THAT THE WIRE PORT WAS CRACKED. THE STENT WAS NOT INSERTED INTO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER OR WHEN REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO USING THE PRODUCT .THE DEVICE WAS NOT PREP AS PER FACILITY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11699562 ↗