PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2910BPXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032039441), received between Mar 30, 2021 and Aug 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 17587436 ↗
• MalfunctionJan 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, A 29 X 10 BILIARY 135 PALMAZ GENESIS BALLOON EXPANDABLE STENT DELIVERY SYSTEM (SDS) CAME OFF OF THE BALLOON PRIOR TO ENTERING THE BODY. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117966 ↗
• MalfunctionApr 18, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED, THE PALMAZ GENESIS PRO 29 X 10 BIL 135 STENT WAS NOTED TO HAVE STRUT UPLIFT ON THE DISTAL END AFTER REMOVAL FROM THE PLASTIC RING. THIS WAS NOTICED AFTER THE PALMAZ WAS HANDED OFF TO THE SCRUB TECH TO PREP. THE DEVICE WAS NEVER USED IN THE PATIENT. THE CASE WAS COMPLETED WITH AN UNKNOWN DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED PRIOR TO REMOVING THE DEVICE. THE DISTAL END OF THE STENT WAS NOTED TO HAVE STENT STRUT UPLIFT. THE STENT DELIVERY SYSTEM (SDS) WAS PREPPED PER THE IFU. THE STENT WAS NOT MANIPULATED DURING THE PREP. THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THE BALLOON WAS NOT INFLATED PRIOR TO INSERTION OF THE SDS. THE RIGHT ILIAC ARTERY WAS THE INTENDED TARGET LESION. THE LESION WAS NOTED TO BE CALCIFIED WITH NO TORTUOSITY. THE DIAMETER OF THE UNCONSTRAINED STENT SIZE WAS 1-2 MM LARGER THAN THE VESSEL DIAMETER. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135057 ↗
• MalfunctionMar 30, 2021Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  AS REPORTED, THE STENT OF A 24MM PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT ON 29MM X 10MM X 135CM OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLGASTY (PTA) BALLOON CATHETER CAME OFF THE PTA BALLOON IN THE BODY. THE DOCTOR DEPLOYED IT IN THE ILIAC. A 32MM PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT ON 39 X 10 X 135CM OPTA PRO PTA BALLOON WAS USED, HOWEVER, THE STENT CAME OFF THE BALLOON IN THE 8F UNKNOWN SHEATH. THE STENT AND THE SHEATH WERE PULLED OUT OF THE PATIENT. ANOTHER 32MM PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT ON 39 X 10 X 135CM OPTA PRO PTA BALLOON WAS USED, HOWEVER, THE SAME ISSUE OCCURRED; THE STENT WAS DISLODGED IN THE SHEATH. THREE DEVICES WERE USED IN THE SAME PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THREE DEVICES WERE USED IN PATIENT. THE DEVICES WERE STORED ON A CART IN THE CATH LAB FOR FOUR MONTHS. THE PRODUCTS WERE STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE DEVICES PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592025 ↗

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.