PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG1910BPXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032038673), received between Aug 21, 2023 and Aug 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2023Defective Component; Defective Component

  AS REPORTED, THE 29X10 PALMAZ GENESIS OPTA PRO WAS ATTEMPTED TO BE INSERTED THROUGH A NON-CORDIS 7F SHEATH. UPON INSERTION THE STENT SLIPPED FROM THE DELIVERY SYSTEM (OUTSIDE THE BODY). THE STENT WAS UNABLE TO BE USED. A SECOND 19X10 PALMAZ GENESIS OPTA PRO WAS INSERTED INTO THE SHEATH. THE STENT MOVED SLIGHTLY BUT WAS ABLE TO BE DELIVERED. THE METAL INSERTION TUBE WAS NOT USED ON THE FIRST STENT BUT WAS USED ON THE SECOND. THERE WAS NO REPORTED INJURY TO THE PATIENT. ULTRASOUND GUIDANCE WAS USED DURING ACCESS. THE TARGET VESSEL WAS THE LEFT COMMON CAROTID ARTERY. THE DEVICE WAS STORED AND OPENED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED TO EITHER DEVICE PRIOR TO USE. THEY WERE PREPPED PER THE IFU WITHOUT DIFFICULTY. THE STENT WAS NOT MANIPULATED DURING PREP ON EITHER DEVICE. THE STENTS WERE PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THE BALLOONS WERE NOT INFLATED OR PARTIALLY INFLATED PRIOR TO INSERTING INTO THE PATIENT. NEGATIVE PRESSURE WAS NOT APPLIED TO EITHER SYSTEM. UNUSUAL FORCE WAS NOT USED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO DIFFICULTY CROSSING THE LESION WITH THE 20X10 (SECOND STENT). THE 10X29 PALMAZ WILL BE RETURNED F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17587724 ↗

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.