PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG5980BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032040393), received between Mar 22, 2021 and May 24, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

• MalfunctionMay 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, DURING PREP, A PALMAZ GENESIS .035¿ 8X59 BILIARY STENT WAS OPENED AND FELL OFF ON THE BACK TABLE BEFORE INSERTING THROUGH THE SHEATH TO THE TREATMENT SITE. A NEW STENT WAS OPENED AND USED TO COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED AS AN ILIAC ARTERY STENTING. THE PRODUCT WAS STORED, AND PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE AND NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE STENT WAS NOT CRIMPED USING A CRIMPING TOOL, OR HAND CRIMP. THE BALLOON WAS NOT PARTIALLY INFLATED TO MAINTAIN THE STENT IN PLACE. THERE WAS NO DAMAGE OR DEFORMATION NOTED ON THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991769 ↗
• InjuryMar 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE 8MM X 59MM X 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON .035¿ OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DELIVERY SYSTEM DISLODGED FROM THE BALLOON INSIDE THE PATIENT. THE PATIENT WAS FINE, BUT THEY HAD TO USE ANOTHER UNKNOWN STENT. THE LEFT ILIAC ARTERY WAS PRE DILATED WITH A POWERFLEX 5 X 40 AT 10 ATMOSPHERES (ATM). THEY CROSSED THE AREA WITH A 9 X 39 GENESIS WITH NO ISSUES PRIOR TO PLACING THE 8 X 59. THE PATIENT HAD A MEDICAL HISTORY OF PERIPHERAL VASCULAR DISEASE. THE INTENDED PROCEDURE/TARGET LESION WAS THE ILIAC ARTERY . VESSEL / LESION CHARACTERISTICS, THE LESION HAD LITTLE CALCIFICATION. THE VESSEL HAD LITTLE TORTUOSITY . THE VESSEL HAD NO ANGULATION. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THE SEGMENT WAS LEFT I THE ILIAC ARTERY. THE PATIENT IS STABLE AFTER THE EVENT. THE DEVICE WILL NOT BE RETURNED AS IT REMAINED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11544683 ↗

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.