PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2970BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032039632), received between Feb 1, 2021 and Feb 1, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryFeb 1, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  DURING AN INTERVENTIONAL PROCEDURE IN THE SUBCLAVIAN, A 7 X 29 PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON AN OPTA PRO DELIVERY SYSTEM WAS TAKEN UP TO 3 ATMOSPHERES (ATM) BUT WOULD NOT TAKE ANYMORE CONTRAST. THE BALLOON HAD RUPTURED AND WAS CAUGHT ON THE STENT. THEY WERE ABLE TO GET ANOTHER BALLOON IN THERE TO TACK UP THE STENT. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. IT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258466 ↗

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.