PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG5990BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032040430), received between Feb 19, 2021 and Feb 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033394); they may or may not involve this specific model.

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.

• InjuryFeb 19, 2021Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A .035¿ 59MM X 90MM X 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DISLODGED BEFORE IT WAS READY TO DEPLOY. THE STENT CAME OFF IN THE WRONG LOCATION BEFORE THE BALLOON WAS INFLATED AND CAUSED DAMAGE TO THE PATIENT¿S LEGS. THE PALMAZ GENESIS STENT HAD TO BE CRUSHED TO THE SIDE OF THE VESSEL AND TWO (2) UNKNOWN STENTS WERE BILATERALLY DEPLOYED TO FIX THE PATIENT¿S LEG. THE DEVICE WAS OPENED IN A STERILE FIELD. THE OPERATOR WAS TRAINED TO USE THE DEVICE. THE INTENDED PROCEDURE WAS AN ILIAC STENT. THE ACCESS SITE WAS FEMORAL. THE LESION WAS MODERATELY CALCIFIED. THERE WAS MODERATE VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). A 7F NON-CORDIS SHEATH WAS USED. A NON-CORDIS GUIDEWIRE WAS USED. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE PRODUCT, NOR ANY OF THE OTHER DEVICES USED WITH IT, HAD BEEN RESTERILIZED. DURING PREP,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349369 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033394. One submission often covers many models, so check the product and lot details in each record.

• Z-1363-2022 · May 20, 2022 · Open, Classified
  PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.