PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2990BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032039793), received between May 25, 2021 and Oct 18, 2021 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A .035¿ 29MM X 90MM X 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON EXPANDABLE STENT DELIVERY SYSTEM (SDS) SLID OFF OF THE BALLOON WHEN ADVANCING THROUGH THE PROCEDURAL SHEATH 7FR 45CM NON-CORDIS SHEATH INTRODUCER WAS USED. THERE WAS NO REPORTED PATIENT INJURY. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE INTENDED PROCEDURE/TARGET LESION WAS THE SUPERIOR MESENTERIC ARTERY. THE INTENDED LESION WAS NOT LOCATED AT THE CAROTID BIFURCATION. THE TARGET LESION VESSEL DIAMETER WAS 8MM. NO GUIDE CATHETER WAS USED. THE DIAMETER OF THE UNCONSTRAINED STENT WAS SIZED 1-2 MM LARGER THAN THE VESSEL DIAMETER. THE TARGET LESION VESSEL LENGTH WAS 20MM. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. A RIGHT FEMORAL APPROACH WAS USED FOR THE DELIVERY OF THE SDS TO THE LESION. THERE WAS

  Patient problems: Insufficient Information

  MAUDE report 12647058 ↗
• MalfunctionJun 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WHEN THE PHYSICIAN PREPPED A PALMAZ GENESIS STENT ON .035¿ 29 X 90 OPTA PRO BALLOON EXPANDABLE-STENT DELIVERY SYSTEM, THE STENT FELL OFF THE BALLOON CATHETER BEFORE IT WAS PLACED IN THE BODY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING. THE PRODUCT WAS INSPECTED PER THE IFU. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND OPENED IN A STERILE FIELD. THE DEVICE PREPPED NORMALLY. THE DEVICE WAS NOT USED IN PATIENT. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO ANOMALIES WERE NOTED AFTER REMOVAL FROM THE PACKAGE. THE INTENDED PROCEDURE/LESION WAS THE ILIAC ARTERY. THERE WAS NO CALCIFICATION IN THE ILIAC ARTERY, HOWEVER THE LESION DID HAVE A 90% STENOSIS. THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE CASE WAS COMPLETED SUCCESSFULLY AFTER THE USE OF ANOTHER PALMAZ DEVICE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS THROWN AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076076 ↗
• MalfunctionMay 25, 2021Structural Problem; Structural Problem

  AS REPORTED BY THE SALES REP, THE 29MM X 90MM X 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON .035¿ OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DELIVERY SYSTEM WAS PLACED IN LEFT ILIAC ARTERY AND ATTEMPT WAS MADE TO DEPLOY. BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM). CATHETER WAS REMOVED. THE DOCTOR COULD NOT SEE STENT IN ARTERY UNDER FLUOROSCOPY. THEY CHECKED CATHETER AND STENT WAS STILL ON THE CATHETER, BEHIND THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FIELD. THE DEVICE WAS USED IN PATIENT. THE DEVICE WAS REMOVED FROM PACKAGING CORRECTLY. THERE WERE NO ANOMALIES NOTED PRIOR TO USE. THE DEVICE WAS PREPPED PER THE IFU GUIDELINES. THERE WAS NO DIFFICULTY NOTED DURING PREP. THE STENT WAS MANIPULATED DURING THE PREP OF THE DEVICE. THE STENT APPEARED TO BE PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THE BALLOON WAS NOT INFLATED OR PARTIALLY INFLATED PRIOR TO INSERTING STENT DELIVERY SYSTEM INTO THE CATHETER. THERE NO WAS RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE DEVICE WAS INSERTED INTO THE GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876203 ↗

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.