PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG3980BPXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032040126), received between Oct 21, 2019 and Jul 21, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A 39MM X 8MM 135CM PALMAZ GENESIS BILIARY STENT DELIVERY SYSTEM (SDS) CAME OFF THE BALLOON WHEN REMOVED FROM ITS PACKAGING. AS A RESULT, THE STENT WAS NOT USED, AND A 7MM X 39MM PALMAZ GENESIS BILIARY STENT DELIVERY SYSTEM (SDS) ON OPTA PRO WAS USED WITHOUT ISSUE TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO OBSERVED DAMAGE TO THE STERILE PACKAGING OF THE DEVICE, AND NO PREPARATION OF THE DEVICE HAD BEEN PERFORMED PRIOR TO THE STENT FALLING OFF THE DELIVERY SYSTEM. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15079764 ↗
• InjuryMay 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A PALMAZ GENESIS 39 X 80 BIL 135 EXPANDED WITHOUT ANY ASSISTANCE; THEREFORE, THE STENT SECURED TO THE VESSEL WALL IN AN AREA IT WAS NOT INTENDED. THE PHYSICIAN HAD TO SNARE THE STENT OUT OF THE PATIENT AND THE PROCEDURE WAS COMPLETED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408243 ↗
• MalfunctionOct 21, 2019Inflation Problem; Device Dislodged or Dislocated; Inflation Problem; Device Dislodged or Dislocated

  AS REPORTED, WHEN THE PHYSICIAN WENT UP WITH THE BALLOON CATHETER TO DEPLOY THE PALMAZ GENESIS STENT, AS THEY TOOK THE BALLOON UP, THEY DID NOT SEE THE BALLOON GO UP. THEY CHECKED THE ENDOFLATOR AND NO ISSUES WITH IT. THEN. THEY WENT DOWN, THEN UP AGAIN WITH THE BALLOON, STILL NOTHING. THEY RETRACTED THE BALLOON TO INSPECT IT AND FOUND THE STENT WAS NO LONGER ON THE BALLOON. THEY LOOKED FOR THE STENT AND LUCKILY FOUND IT IN THE CALCIFIC LESION THEY WERE TRYING TO TREAT. THEY TOOK ANOTHER SMALL BALLOON AND POST DILATED THE STENT. THEN WITH A LARGER BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE STENT WAS EVENTUALLY DEPLOYED IN THE PROPER LESION WITH GOOD OUTCOME BUT THERE MUST HAVE BEEN A PIN HOLE IN THE BALLOON OR SOMETHING THAT WASN¿T TAKING IT UP ALL THE WAY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS DISPOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215572 ↗

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.