PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2970BPXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032039649), received between Aug 6, 2019 and May 6, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A PALMAZ LONG GENESIS ON .035¿ 29 X 70 X 135 OPTA PRO BALLOON EXPANDABLE STENT DELIVERY SYSTEM WAS SUSPECTED TO HAVE A LEAK AND WOULD NOT HOLD PRESSURE DURING INFLATION TO FULLY EXPAND/DEPLOY THE STENT. THEREFORE, IT WAS REPLACED WITH A NON-CORDIS BALLOON TO FINISH EXPANDING THE STENT TO PROFILE IN THE RIGHT RENAL ARTERY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS STORED AND MONITORED IN THE WAVEMARK TECHNOLOGY CABINETS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11785693 ↗
• MalfunctionAug 6, 2019Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  AS REPORTED, A PALMAZ GENESIS LONG PRO 29 X 70 BIL 125 ENDOVASCULAR BALLOON-EXPANDABLE STENT (SDS) BECAME DISLODGED FROM THE BALLOON AND WAS UNABLE TO BE RECOVERED. THERE WAS NO REPORTED PATIENT INJURY. THE STENT WAS DEPLOYED IN THE PATIENT¿S RADIAL ARTERY, NOT THE DESIRED DESTINATION. THE STENT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE TARGET LESION WAS IN THE RIGHT RENAL ARTERY. THERE WAS A LITTLE VESSEL TORTUOSITY. THERE WAS MODERATE VESSEL ANGULATION. THE DEVICE WAS NOT BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THE PRODUCT LOOKED NORMAL WHEN IT WAS REMOVED FROM THE PACKAGING. THERE WAS NOT ANY DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NOT ANY DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NOT ANY DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NOT ANY KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS 100% CONTRAST USED FOR ROADMAPPING. THE INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER, THE GUIDE WAS REMOVED AND THEY WENT BARE BACK ON THE WIRE. THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8866518 ↗

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.