PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG3990BPXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032040201), received between Feb 21, 2019 and Mar 10, 2022 — classified as 1 injury, 3 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.

• MalfunctionMar 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WHEN THE STAFF OPENED A 9X40 PALMAZ GENESIS ® TRANSHEPATIC BILIARY STENT ON OPTA PRO .035" DELIVERY SYSTEM IN THE APPROPRIATE MANNER AND WHEN THEY PLACED IT ON THE STERILE FIELD THEY SAW THE STENT HAD FALLEN OFF THE BALLOON. SO THEY COULD NOT USE THAT DEVICE SINCE THE STENT FELL OFF SO THEY OPENED ANOTHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REPLACEMENT DEVICE. THERE WAS NO REPORTED PATIENT INJURY. AN ILIAC CASE WAS BEING PERFORMED. THERE WAS NO DAMAGE TO THE PRODUCT PACKAGING. THE DEVICE WAS STORED IN THE OPERATING ROOM ON A CART. THERE WAS NO DIFFICULTY REMOVING THE PALMAZ GENESIS DEVICE FROM THE PACKAGING AND NO DIFFICULTY DURING ANY PREPARATION OF THE DEVICE PRIOR TO THE REPORTED EVENT. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13723024 ↗
• MalfunctionApr 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE DOCTOR PREP THE 39MM X 90MM X 135CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON .035¿ OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DELIVERY SYSTEM AND THE STENT FELL OFF THE PTA. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FIELD. THE DEVICE WAS NOT USED IN PATIENT. THE INTENDED PROCEDURE WAS AN ILIAC ARTERY LESION. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO OTHER ANOMALIES NOTED DURING PREP. THE DEVICE WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE USER WAS TRAINED WITH THE DEVICE. THE STENT WAS NOT MANIPULATED DURING PREP. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11684083 ↗
• InjuryApr 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A PALMAZ LONG GENESIS STENT ON .035" 39 X 90 X 135 OPTA PRO BALLOON EXPANDABLE STENT DELIVERY SYSTEM DISLODGED BEFORE DEPLOYING IN THE WRONG LOCATION IN THE PATIENT¿S BODY. IT RESULTED IN PATIENT HAVING TO HAVE TWO UNKNOWN EXTRA BILATERAL KISSING STENTS TO CRUSH STENT TO VESSEL WALL. THE OPERATOR WAS TRAINED TO USE THE DEVICE. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WAS STORED ON A SHELF IN THE CATH LAB, FOR LESS THAN THREE MONTHS. THE PRODUCT WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR OR AFTER TO INSERTING THE PRODUCT INTO THE PATIENT. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK OR BEND AT ANY TIME. THERE WAS NO KINKS TO ANY PART OF THE DEVICE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO ATTEMPT MADE TO RECAPTURE THE STENT. THE TARGET LESION WAS THE ILIAC, WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604057 ↗
• MalfunctionFeb 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, A PALMAZ STENT (LONG GEN / PRO 39 X 90 BIL 135) SLIPPED OFF THE BALLOON PREMATURELY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THE STENT WAS IMPLANTED IN THE PATIENT'S DIALYSIS GRAFT AND THE BALLOON WAS DISCARDED. THE TYPE OF PROCEDURE WAS A FISTULAGRAM WITH EMBOLECTOMY. THE TARGET SITE WAS THE VENOUS ANASTOMOSIS. THE ACCESS SITE WAS A LATERAL FOREARM GRAFT. THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE ACCESS AND TARGET SITES WERE A POST EMBOLECTOMY DIALYSIS GRAFT. THERE WAS NO CALCIFICATION, NO TORTUOUSITY, NO ACUTE ANGLES, NO BIFURCATION. THERE WAS STENOSIS AT THE VENOUS ANASTOMOSIS, WHICH WAS THE INTENDED TARGET FOR DEPLOYMENT. THE DEVICE WAS NOT BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. NEITHER THE PRODUCT, NOR ANY OF THE OTHER DEVICES USED WITH IT HAD BEEN RESTERILIZED. DURING PREP, THE STENT WAS NOT MANIPULATED. THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THE SDS WAS PREPPED ACCORDING TO IFU GUIDELINES. THE SHEATH USED WAS A 7F NON-CORDIS DEVICE. THE GUIDEWIRE USED WAS A .035 NON-CORDIS DEVICE. PRIOR TO INSERTING THE SDS IN T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8358161 ↗

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.