Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System PB1570BSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032035986), received between Apr 30, 2019 and Jan 6, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 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, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Inflation Problem; Inflation Problem

  AS REPORTED, A 7X15 80 PALMAZ BLUE TRANSHEPATIC BILIARY BALLOON EXPANDABLE STENT DELIVERY SYSTEM WAS DEFECTIVE AND DID NOT EXPAND DURING DELIVERY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PER LABELING AND OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112490 ↗
• MalfunctionOct 3, 2019Defective Component; Defective Component

  PRIOR TO USE IN THE PATIENT, THE PALMAZ BLUE/SLALOM 7X15/80 BALLOON STENT DELIVERY SYSTEM ¿BROKE¿ AS THE STENT WAS LOOSE ON THE BALLOON. THERE WAS NO PATIENT INJURY. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152621 ↗
• MalfunctionJul 24, 2019Defective Component; Defective Component

  AS REPORTED, A PALMAZ BLUE SLALOM 7X15/80 ENDOVASCULAR BALLOON-EXPANDABLE STENT (SDS) WAS LOOSE ON THE BALLOON, THE PRODUCT WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8822490 ↗
• MalfunctionApr 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF THE BLUE/SLALOM 7X15/80 BIL PACKAGED FELL OFF THE DELIVERY SYSTEM WHILE PREPPING THE DEVICE. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS STORED IN THE CATH LAB FOR APPROXIMATELY ONE TO TWO MONTHS. THE PRODUCT WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WAS NO KINK TO ANY PART OF THE DEVICE. THERE WAS NOTHING UNUSUAL NOTED TO THE STENT DELIVERY SYSTEM PRIOR TO USE. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME. THE PROCEDURE WAS COMPLETED BY USING A NEW 7X15X80 PALMAZ BLUE STENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8564520 ↗