PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG3910BPXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032039847), received between Mar 30, 2021 and Jun 28, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Therapy Delivered to Incorrect Body Area” (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.

• MalfunctionJun 28, 2021Crack; Inflation Problem; Device Dislodged or Dislocated; Material Protrusion/Extrusion; Crack; Inflation Problem; Device Dislodged or Dislocated; Material Protrusion/Extrusion

  DURING THE PROCEDURE, WHEN THE PROVIDER ATTEMPTED TO PLACE A PALMAZ GENESIS STENT ON A .035¿ 39 X 10 X 135 OPTA PRO BALLOON EXPANDABLE STENT DELIVERY SYSTEM, HOWEVER, THE STENT DID NOT DEPLOY IN THE ARTERY OR UNKNOWN STENT GRAFT. THE PROVIDER PULLED THE DEVICE, AND IT WAS STILL ATTACHED TO THE BALLOON. THEREFORE, ANOTHER UNKNOWN STENT WAS USED, AND IT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073595 ↗
• MalfunctionMar 30, 2021Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  AS REPORTED, THE STENT OF A 24MM PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT ON 29MM X 10MM X 135CM OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLGASTY (PTA) BALLOON CATHETER CAME OFF THE PTA BALLOON IN THE BODY. THE DOCTOR DEPLOYED IT IN THE ILIAC. A 32MM PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT ON 39 X 10 X 135CM OPTA PRO PTA BALLOON WAS USED, HOWEVER, THE STENT CAME OFF THE BALLOON IN THE 8F UNKNOWN SHEATH. THE STENT AND THE SHEATH WERE PULLED OUT OF THE PATIENT. ANOTHER 32MM PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT ON 39 X 10 X 135CM OPTA PRO PTA BALLOON WAS USED, HOWEVER, THE SAME ISSUE OCCURRED; THE STENT WAS DISLODGED IN THE SHEATH. THREE DEVICES WERE USED IN THE SAME PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THREE DEVICES WERE USED IN PATIENT. THE DEVICES WERE STORED ON A CART IN THE CATH LAB FOR FOUR MONTHS. THE PRODUCTS WERE STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE DEVICES PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592245 ↗
• MalfunctionMar 30, 2021Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  AS REPORTED, THE STENT OF A 24MM PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT ON 29MM X 10MM X 135CM OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLGASTY (PTA) BALLOON CATHETER CAME OFF THE PTA BALLOON IN THE BODY. THE DOCTOR DEPLOYED IT IN THE ILIAC. A 32MM PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT ON 39 X 10 X 135CM OPTA PRO PTA BALLOON WAS USED, HOWEVER, THE STENT CAME OFF THE BALLOON IN THE 8F UNKNOWN SHEATH. THE STENT AND THE SHEATH WERE PULLED OUT OF THE PATIENT. ANOTHER 32MM PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT ON 39 X 10 X 135CM OPTA PRO PTA BALLOON WAS USED, HOWEVER, THE SAME ISSUE OCCURRED; THE STENT WAS DISLODGED IN THE SHEATH. THREE DEVICES WERE USED IN THE SAME PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THREE DEVICES WERE USED IN PATIENT. THE DEVICES WERE STORED ON A CART IN THE CATH LAB FOR FOUR MONTHS. THE PRODUCTS WERE STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE DEVICES PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592038 ↗

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.