PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG3910BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032039830), received between Mar 29, 2021 and Jan 26, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2024Deflation Problem; Device Dislodged or Dislocated; Deflation Problem; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A 4MM X 18MM PALMAZ BLUE ON AVIATOR PLUS STENT DELIVERY SYSTEM (SDS) DISLODGED FROM THE BALLOON WITHIN THE RENAL ARTERY AND THE BALLOON WAS UNABLE TO BE DEFLATED. AS A RESULT, THE DELIVERY SYSTEM WAS INTENTIONALLY CUT, AND THE BALLOON WAS DEFLATED WITH A SYRINGE TO REMOVE ENTIRE DELIVERY SYSTEM FROM THE PATIENT AND. A PERIPHERAL RETRIEVABLE FILTER TRAP WAS THEN USED TO CAPTURE AND RETRIEVE THE DISLODGED STENT AND THE PROCEDURE WAS COMPLETED. THIS WAS DURING A PROCEDURE TO TREAT VERTEBRAL ARTERY STENOSIS. THE LESION HAD MODERATE CALCIFICATION, MILD TORTUOSITY, AND A 75% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. A NON-CORDIS BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION. THE AVIATOR PLUS SDS WAS NOT KINKED AT ANY TIME DURING THIS PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586545 ↗
• MalfunctionDec 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, WHEN REMOVING A 39MM X 10MM PALMAZ GENESIS ON OPTA PRO STENT DELIVERY SYSTEM (SDS), THE STENT FELL OFF OF THE BALLOON. THE STENT WAS NOT MANIPULATED AND FELL OFF OF THE DEVICE PRIOR TO PREPARATION. THE DEVICE NEVER WENT INTO THE PATIENT AND A NON-CORDIS STENT WAS USED TO TREAT THE INTENDED LESION. THERE WERE NO PATIENT INJURIES REPORTED. THE PALMAZ GENESIS STENT WAS TO BE IMPLANTED IN THE ILIAC ARTERY DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE PACKAGING WAS OPENED CORRECTLY, AND THE STENT DID NOT APPEAR PREMATURELY EXPANDED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18284450 ↗
• MalfunctionMay 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A 39MM X 10MM PALMAZ GENESIS BILIARY ON OPTA PRO .035 STENT DELIVERY SYSTEM (SDS) FELL OF DURING PREPARATION, PRIOR TO PATIENT USE. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919906 ↗
• InjuryMar 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS CANNULATING THE ILIAC ARTERY, HOWEVER, WHEN TRYING TO PLACE A 32MM PALMAZ LONG GENESIS BILIARY STENT ON .035¿ 39 X 10 X 80 OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER; THE STENT SLIDES OFF THE BALLOON PRIOR TO PROPER PLACEMENT AND PROPER DEPLOYMENT/INFLATION. PHYSICIAN WAS ABLE TO SAVE THE STENT USING VARIOUS TECHNIQUES. NO HARM WAS DONE TO THE PATIENT. THE PRODUCT WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THE ACCESS SITE WAS FEMORAL. THE LESION HAD LITTLE CALCIFICATION. THERE WAS LITTLE VESSEL TORTUOSITY. A 7F CORDIS BRITE TIP SHEATH WAS USED. A .035 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, OR ANY OF THE OTHER DEVICES USED WITH IT, HAD NOT BEEN RESTERILIZED. DURING PREP, THE STENT WAS NOT MANIPULATED. 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 NOR PARTIALLY INFLAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582696 ↗

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.