PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2910BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032039434), received between Jan 11, 2022 and May 1, 2024 — 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.

• MalfunctionMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE DR. PREDILATED A RIGHT COMMON ILIAC THAT HAD A DISSECTION PLANE. AFTER ADVANCING THE 29 X 10 LONG PALMAZ GENESIS STENT INTO THE BODY THROUGH A 7F 10CM UNKNOWN SHEATH, THE DR. BECAME AWARE THAT THE STENT WAS NO LONGER ON THE BALLOON BUT FLOATING FREE (STILL ON THE WIRE) DISTAL TO THE INTENDED DEPLOYMENT SITE. THE PHYSICIAN WAS ABOUT TO ADVANCE A HYDROPHILIC WIRE THROUGH THE STENT EXCHANGE FOR AN .014 SYSTEM AND USE A PARTIALLY INFLATED 5X40 .014 BALLOON TO DRAG IT BACK INTO PLACE AND PARTIALLY DEPLOY IT. THE BALLOON CATHETER WAS REMOVED EASILY FROM THE PATIENT. THE DR. THEN SWITCHED BACK TO AN .035 SYSTEM AND USED THE INITIAL DEPLOYMENT BALLOON TO EXPAND THE STENT IN THE DESIRED AREA. NO HARM WAS DONE TO THE PATIENT. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED PRIOR TO USE. THE SDS WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY NOTED DURING PREP. THE STENT WAS NOT MANIPULATED DURING PREP. THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED AND PRIOR TO USE. THE BALLOON WAS NOT INFLATED OR PARTIALLY INFLATED PRIOR TO INSERTING THE SDS IN THE CATHETER. NEGATIVE PRESSURE WAS NOT APPLIED TO THE SDS. THE INFLATION DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219911 ↗
• MalfunctionOct 29, 2022Device Dislodged or Dislocated; Material Protrusion/Extrusion; Device Dislodged or Dislocated; Material Protrusion/Extrusion

  AS REPORTED, THE STENT ON A 29MM X 10MM 80CM PALMAZ GENESIS BILIARY STENT DELIVERY SYSTEM (SDS) SLID OFF THE BALLOON WHILE PASSING THROUGH THE HUB OF A 7F 45CM NON-CORDIS CATHETER SHEATH INTRODUCER (CSI). THE STENT HAD SLID PROXIMALLY ON THE DEVICE AND REMAINED ON THE DELIVERY SYSTEM, JUST PROXIMAL TO THE BALLOON. THE STENT DELIVERY SYSTEM WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT WITH THE STENT STILL ATTACHED TO THE DEVICE. A NEW 10MM X 29MM PALMAZ GENESIS SDS WAS THEN USED AND WAS SUCCESSFULLY IMPLANTED IN THE ILIAC ARTERY WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 70% STENOSED LESION IN THE COMMON ILIAC ARTERY WHICH HAD MILD CALCIFICATION AND VESSEL TORTUOSITY. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY PREPPING THE DEVICE. THE STENT WAS NOT MANIPULATED DURING PREPARATION AND WAS PROPERLY MOUNTED ON THE DELIVERY SYSTEM WHEN INSPECTED PRIOR TO USE. A 7F 45CM NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS INITIALLY USED FOR THIS ACCESS IN THIS PROCEDURE. THERE WAS NO OBSERVED DAMAGE TO THIS CSI; HOWEVER, IT WAS REPORTED THAT A SECOND 7F 45CM NON-CORDIS CSI WAS USED TO REPLACE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696919 ↗
• MalfunctionJan 11, 2022Structural Problem; Material Protrusion/Extrusion; Structural Problem; Material Protrusion/Extrusion

  AS REPORTED, A PALMAZ GENESIS LONG PRO BIL 29MM X 10MM X 80CM STENT DELIVERY SYSTEM (SDS) WOULD NOT CROSS A CALCIFIED COMMON ILIAC LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN STENT. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. AN IPSILATERAL APPROACH WAS USED. THE COMMON ILIAC HA MODERATE CALCIFICATION, MILD TORTUOSITY, 70% STENOSIS, ACUTE ANGULATION, NO BIFURCATION, AND NOT A CTO. THE DEVICE DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE REPORTED COMPLAINT. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE USER WAS TRAINED WITH THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION. DURING VISUAL INSPECTION OF THE RETURNED DEVICE, THE STENT WAS OBSERVED SLIGHTLY MOVED FROM ITS ORIGINAL POSITION AND PARTIALLY OPENED FROM THE INITIAL SECTION OF THE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225291 ↗

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.