PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG3990BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032040195), received between Aug 21, 2017 and May 24, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, A 35MM PALMAZ LONG GENESIS STENT ON A 39 X 90 X 80CM OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON-EXPANDABLE STENT DELIVERY SYSTEM, WAS ADVANCED PAST THE LESION. HOWEVER, UPON PULLING IT BACK TO THE LESION, THE STENT WAS DISLODGED PRIOR TO REACHING THE DESIRED LOCATION AND PRIOR TO INFLATION WITH THE UNKNOWN INDEFLATION DEVICE. THE PHYSICIAN HAD TO USE AN ENSNARE DEVICE TO REMOVE THE STENT FROM THE BODY. THE 300CM STORQ STEERABLE GUIDEWIRE WAS LEFT IN THE POSITION AND ONCE IT WAS REMOVED, THE PROCEDURE CONTINUED, AND THE PHYSICIAN SUCCESSFULLY PLACED A 9 X 29 BX GENESIS/OPTAPRO STENT USING NORMAL TECHNIQUE. THE PATIENT DID WELL, AND NO OTHER NECESSARY POST PROCEDURE TREATMENT WAS REQUIRED. THE SALES REP WAS PRESENT DURING THE PROCEDURE. THE INTENDED PROCEDURE IS A PTA STENT OF THE LEFT SUBCLAVIAN PROXIMAL ARTERY. INITIALLY, THE PHYSICIAN POSITIONED THE 7F 70CM UNKNOWN SHEATH AND ENGAGED IN THE OSTIUM OF THE LEFT SUBCLAVIAN ARTERY. THE 300CM ANGLED STORQ WIRE WAS ADVANCED DISTAL TO THE LESION. ANGIOGRAMS WERE OBTAINED AND VISUALIZATION OF THE PLACEMENT WAS CONFIRMED. THE VESSEL WAS SEVERELY CALCIFIED AND TORTUOUS. THE DOCTOR WAS TRAINED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870696 ↗
• InjuryDec 9, 2019Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  AS REPORTED, A 9MM X 39MM 80CM BILIARY LONG GENESIS PRO STENT CAME OFF THE BALLOON PRIOR TO LANDING IN THE ILIAC ARTERY. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN WANTED TO STENT THE ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9439271 ↗
• InjuryAug 21, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING OR AFTER USE, IT WAS REPORTED THAT THE STENT CAME OFF THE PALMAZ GENESIS ON PRO BALLOON PREMATURELY AND SLID OFF. VASCULAR SURGERY WAS NEEDED. THERE WERE NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6807402 ↗

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.