Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System PB2470BSXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032036358), received between Oct 29, 2020 and Sep 21, 2023 — classified as 1 injury, 1 malfunction.

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

• MalfunctionSep 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE 7X24MM PALMAZ BLUE BILIARY STENT WAS NOT SEEN. AFTER SOME SEARCHING IT WAS FOUND THAT THE BALLOON MOUNTED STENT HAD FALLEN OFF THE BALLOON BEFORE IT WAS EVER ENTERED INTO THE SHEATH, SO THE STENT HAD FALLEN OFF AS SOON AS THE DELIVERY SYSTEM WAS DROPPED ONTO THE STERILE FIELD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 7X24 STENT. THERE WAS NO REPORTED PATIENT INJURY. THE STENT WAS TO BE USED DURING AN INTERVENTIONAL VASCULAR PROCEDURE. THE STENT DELIVERY SYSTEM WAS OPENED ONTO THE TABLE AND PREPPED IN THE NORMAL FASHION. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE NOR DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE CATHETER HAD ENTERED THE PATIENT AND THE BALLOON WAS INFLATED NORMALLY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793371 ↗
• InjuryOct 29, 2020Fracture; Migration; Fracture; Migration

  APPROXIMATELY NINE DAYS AFTER A 7.0 X 24 135CM PALMAZ BLUE ENDOVASCULAR BALLOON-EXPANDABLE STENT (SDS) ON A SLALOM WAS IMPLANTED IN THE ABDOMEN, PART OF THE STENT WAS IN THE ABDOMEN BUT THERE WAS ALSO A PART OF IT THAT MOVED DOWN TO THE VESSEL IN THE THIGH. FORTUNATELY,¿ IT WAS VERY SOLID THERE¿ AND THERE WAS NO REPORTED RISK TO THE PATIENT. THE PHYSICIAN REPORTED THAT THE PATIENT WAS CONSIDERED ELDERLY AND VERY SICK. (AN) OPERATION HAD NO ADVANTAGES OR DISADVANTAGES FOR THE PATIENT. THE DEVICE WAS PROPERLY OPENED IN STERILE FIELD IS NOT AVAILABLE FOR EVALUATION. A PROCEDURAL CD IS AVAILABLE FOR REVIEW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10755176 ↗