PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG3970BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032040034), received between Sep 2, 2022 and Aug 14, 2023 — classified as 2 injuries.

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

• InjuryAug 14, 2023Leak/Splash; Therapy Delivered to Incorrect Body Area; Leak/Splash; Therapy Delivered to Incorrect Body Area

  AS REPORTED, THE 39 X 70 PALMAZ GENESIS PRO STENT PARTIALLY DEPLOYED, AND THE BALLOON MALFUNCTIONED BEFORE INFLATION. THE STENT WAS NOT WITHIN THE INTENDED LESION. A SECOND STENT WAS NEEDED TO COVER THE LESION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DAMAGE WAS NOTED AFTER THE DEVICE WAS INSERTED INTO THE VESSEL. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED PRIOR TO USE. THE SDS WAS PREPPED ACCORDING TO IFU GUIDELINES WITHOUT DIFFICULTY. THE STENT WAS NOT MANIPULATED DURING PREP. THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. PRIOR TO INSERTING THE SDS IN THE CATHETER, THE BALLOON WAS NOT INFLATED OR PARTIALLY INFLATED. THE LESION WAS NOTED TO BE CALCIFIED. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539916 ↗
• InjurySep 2, 2022Migration; Migration

  AS REPORTED, AFTER DEPLOYMENT OF A 39MM X 70MM 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT DELIVERY SYSTEM (SDS) ON .035 OPTA PRO, THE STENT MOVED LOCATIONS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352681 ↗

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.