PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2990BPXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032039809), received between Jul 28, 2020 and Mar 4, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A 29MM X 90MM PALMAZ GENESIS ON OPTA PRO STENT DELIVERY SYSTEM (SDS) CAME OFF OF THE BALLOON INSIDE OF AN UNKNOWN CATHETER SHEATH INTRODUCER (CSI) PRIOR TO DEPLOYMENT. THERE WAS NO DIFFICULTY REMOVING THE DELIVERY SYSTEM FROM THE PATIENT, AND THE STENT WAS ABLE TO BE REMOVED BY REMOVING THE SHEATH FROM THE PATIENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A SUBCLAVIAN LESION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THE STENT WAS NOT MANIPULATED PRIOR TO INSERTION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832459 ↗
• MalfunctionNov 24, 2021Loss of or Failure to Bond; Premature Activation; Device Dislodged or Dislocated; Material Protrusion/Extrusion; Loss of or Failure to Bond; Premature Activation; Device Dislodged or Dislocated; Material Protrusion/Extrusion

  AS REPORTED, THE STENT OF A LONG GENESIS/PRO 29 X 90 BIL 135 STENT DELIVERY SYSTEM (SDS) FELL OFF THE BALLOON. WHEN THEY WERE INSPECTING THE STENT BEFORE INSERTING INTO THE BODY, THE DOCTOR SAW IT WAS NOT CRIMPED SECURELY ON THE BALLOON. THE DOCTOR TRIED TO MANUALLY CRIMP THE STENT ON THE BALLOON BY HAND AND ALSO TRIED TO ROLL THE STENT AND BALLOON ON THE TABLE TECHNIQUE TO GET THE STENT ON THE BALLOON, BUT WAS UNSUCCESSFUL. THE PHYSICIAN WAS NOT CONFIDENT IN USING THE DEVICE FOR THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER, SMALLER PALMAZ GENESIS STENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE NEVER WENT IN THE BODY. DEVICE PACKAGING LOOKED NORMAL AND DID NOT HAVE DAMAGE. THE PHYSICIAN IS TRAINED AND HAS USED THE DEVICE IN THE PAST. THE TARGET LESION WAS A RENAL ARTERY. THE PHYSICIAN NOTICED THE STENT WAS LOOSE ON THE BALLOON AND TRIED TO "CRIMP/ROLL" THE STENT BACK, BUT WAS UNSUCCESSFUL. THE DILATION CATHETER OF THE SDS WAS SUCCESSFULLY USED LATER IN THE PROCEDURE TO POST DILATE. THE DEVICE WILL BE RETURNED FOR ANALYSIS. ADDENDUM: PRODUCT ANALYSIS REVEALS THE STENT WAS OBSERVED PARTIALLY EXPANDED AND SOME STRUTS WERE OBSERVED BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868030 ↗
• MalfunctionJun 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, A PALMAZ LONG GENESIS STENT ON .035" 29 X 90 X 135 OPTA PRO BALLOON EXPANDABLE STENT DELIVERY SYSTEM WAS PUT ON THE WIRE (UNKNOWN); HOWEVER, IT COMPLETELY MOVED OFF THE BALLOON AND IT SLID BACK AND FORTH. THE EVENT WAS NOTICED BEFORE IT GOT TO THE SHEATH (UNKNOWN). THEREFORE, A NEW STENT (UNKNOWN) WAS OPENED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION. THERE WAS NO DAMAGE NOTED ON THE PACKAGING. THE DEVICE WAS STORED ACCORDING TO THE IFU. DURING REMOVAL FROM THE INNER PACKAGING, THE TRAY WAS CAREFULLY EXTRACTED WITH THE STENT AND DELIVERY SYSTEM AND INTRODUCER TUBE. THE TRAY WAS HELD IN ONE HAND AND WITH THE OTHER HAND, AND THE STAFF GENTLY GRASPED THE HUB AND CAREFULLY REMOVED THE STENT/DELIVERY SYSTEM FROM THE TRAY. WHEN THE DEVICE WAS INSPECTED, IT WAS NOT ADHERED TO THE BALLOON, SO A NEW STENT WAS OPENED. THERE HAD BEEN NO REPOSITIONING OR HAND CRIMP. BEFORE ATTEMPTING TO LOAD THE DEVICE ONTO THE WIRE, THE DEVICE WAS PREPPED PER IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935380 ↗
• MalfunctionFeb 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, WHEN THE BALLOON OF A .035¿ 29MM X 30MM X 135CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON EXPANDABLE STENT DELIVERY SYSTEM (SDS) CAME OUT OF THE 7F NON-CORDIS SHEATH, THERE WAS NO STENT ON IT. THE PHYSICIAN SEARCHED ALL VESSELS FROM HEAD TO TOE ON FLURO BUT COULD NOT FIND A DISLODGED STENT. HE ALSO CHECKED IF IT WAS IN THE ¿SHUTTLE SHEATH¿ BUT FOUND NOTHING. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON WAS REMOVED TO INSPECT IT TO SEE IF THE STENT WAS ON IT. AFTERWARDS, THE PHYSICIAN USED THE SAME BALLOON FOR ANGIOPLASTY THE LESION. THE LESION WAS THE RIGHT COMMON CAROTID WHICH WAS CALCIFIED, TORTUOUS, AT A BIFURCATE AND IN AN ACUTE ANGLE WITH NINETY-FIVE PERCENT STENOSIS. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE ACCESS SITE WAS FEMORAL, AND A CONTRALATERAL APPROACH USED. A COMPETITOR¿S SHEATH AND AN AQUATRACK GUIDEWIRE WERE USED. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298405 ↗
• MalfunctionJul 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, AFTER BACKING OUT THE 29 X 90 X 135 PALMAZ LONG GENESIS TRANSHEPATIC BILIARY STENT, THE USERS NOTICED THE STENT LAYING ON THE DRAPE UNDEPLOYED. THEREFORE, THE USERS DEPLOYED A NON-CORDIS STENT. THERE WAS NO REPORTED PATIENT INJURY. INITIALLY, THE USERS WENT TO LOAD THE DEVICE ON AN UNKNOWN WIRE AND DEPLOYED IT, HOWEVER, AFTER DEPLOYMENT, THE USERS WERE NOT ABLE TO SEE THE STENT UNDER FLOUROSCOPY (FLURO). AFTER THE USERS DEPLOYED A NON-CORDIS STENT, THEY CHECKED THE PALMAZ DEVICE SINCE THEY NEVER HAD THIS HAPPENED. THE DOCTOR PUT THE STENT ONTO THE UNKNOWN BALLOON AND PARTIALLY DEPLOYED IT, CURIOUS TO KNOW IF IT WAS THE STENT OR NOT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10334141 ↗

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.