PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG3980BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032040119), received between Apr 14, 2020 and Sep 2, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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.

• InjurySep 2, 2022Migration; Migration

  AS REPORTED, ONCE THE PALMAZ GENESIS 39 X 80 STENT WAS DEPLOYED; HOWEVER, IT MOVED LOCATIONS AN NEW STENT WAS USED WHICH WORKED GOOD. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WERE NO ANOMALIES NOTED PRIOR TO USE. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS REMOVED FROM PACKAGING IN A STERILE MANNER ACCORDING TO THE INDICATIONS, REMOVED FROM ITS PACKAGING AND ¿FLUSHED¿ BEFORE USE. THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THERE WERE NO ABNORMALITIES NOTED PRIOR TO USE. THE SDS WAS PREPARED IN ACCORDANCE WITH THE IFU GUIDELINES. THERE WAS NO DIFFICULTY NOTED DURING PREP. THE STENT WAS NOT MANIPULATED PRIOR TO INSERTING INTO THE PATIENT, IT WAS ONLY FLUSHED WITH A HEPARIN SOLUTION PRIOR TO INSERTION. THE LESION WAS IN THE RIGHT AND LEFT ILIAC AND ANGIOPLASTY WAS BEING PERFORMED. THE LESION WAS NOTED TO BE CALCIFIED. THE VESSEL DID NOT HAVE ANY TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). AN UNKNOWN 6F SHEATH WAS USED ALONG WITH A NON-CORDIS 150CM WIRE. A NON-CORDIS 5F 65CM GUIDE CATHETER WAS ALSO USED. THE BALLOON ON THE SYSTEM WAS NOT INFLATED BEFORE INSERTING INTO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352678 ↗
• MalfunctionMay 28, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE PHYSICIAN WANTED TO DEPLOY THE 8MM X 39MM X 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT HOWEVER, THE BALLOON BURST. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10098629 ↗
• MalfunctionApr 14, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO (2) .035" X 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENTS ON OPTA PRO BURST. THE BALLOONS WERE RETRIEVED/REMOVED, AND ANOTHER UNKNOWN BALLOON WAS USED TO POST-DILATE THE STENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR ANGIOPLASTY PROCEDURE. THE TARGET LESION WAS THE LEFT COMMON ILIAC. THERE WAS MODERATE CALCIFICATION OF THE LESION. THERE WAS 70-90% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE TYPE OF INFLATION DEVICE USED WAS A SYRINGE AND IT WAS THE SAME DEVICE SUCCESSFULLY USED WITH OTHER DEVICES. THE MAXIMUM INFLATION PRESSURE AND AT WHAT ATMOSPHERE DID THE BALLOON BURST WAS HARD TO EVALUATE BECAUSE A SYRINGE WAS USED. THE PRODUCTS WERE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. OTHER ADDITIONAL PATIENT/PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICES WILL NOT BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957494 ↗
• MalfunctionApr 14, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO (2) .035" X 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENTS ON OPTA PRO BURST. THE BALLOONS WERE RETRIEVED/REMOVED, AND ANOTHER UNKNOWN BALLOON WAS USED TO POST-DILATE THE STENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR ANGIOPLASTY PROCEDURE. THE TARGET LESION WAS THE LEFT COMMON ILIAC. THERE WAS MODERATE CALCIFICATION OF THE LESION. THERE WAS 70-90% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE TYPE OF INFLATION DEVICE USED WAS A SYRINGE AND IT WAS THE SAME DEVICE SUCCESSFULLY USED WITH OTHER DEVICES. THE MAXIMUM INFLATION PRESSURE AND AT WHAT ATMOSPHERE DID THE BALLOON BURST WAS HARD TO EVALUATE BECAUSE A SYRINGE WAS USED. THE PRODUCTS WERE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. OTHER ADDITIONAL PATIENT/PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICES WILL NOT BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957419 ↗

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.