PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2480BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032039267), received between Aug 11, 2021 and Aug 11, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryAug 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, A 24 X 80 BIL 80 GENESIS EXPANDABLE STENT ON OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PTA BALLOON CATHETER WAS ATTEMPTED TO BE PLACED; HOWEVER, THE STENT WAS DISLODGED FROM THE OPTA PRO IN THE DISTAL RIGHT ILIAC. THE DISLODGED STENT THEN REQUIRED A RETRIEVAL WITH AN EN-SNARE RETRIEVAL DEVICE (UNKNOWN) STARTING WITH INTRODUCING AN 8F SHEATH (UNKNOWN) FOR THE RETRIEVAL. ONCE THE STENT WAS SNARED AND RETRACTED FROM THE ARTERY, THE STENT THEN COLLAPSED ON ITSELF AT THE TIP OF THE UNKNOWN SHEATH, FORCING THE PHYSICIAN TO REMOVE THE UNKNOWN SHEATH, UNKNOWN SNARE AND STENT TOGETHER FROM THE ARTERY. THE REMOVAL OF THE STENT LED TO A SURGICAL CUTDOWN DUE TO THE TRAUMA OF THE ARTERY CAUSED BY THE STENT COLLAPSING CREATING A LARGER ENTRANCE SITE IN THE ARTERY REQUIRING SUTURES TO ENSURE HEMOSTASIS. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY MISTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310504 ↗

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.