PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2980BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032039717), received between Apr 14, 2017 and Jun 22, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• MalfunctionJun 22, 2021Defective Component; Defective Component

  BEFORE PREP, THE OPERATOR NOTICED THE 29 X 80 X 80 PALMAZ GENESIS TRANSHEPATIC BILIARY STENT DELIVERY SYSTEM (SDS) ON .035" OPTA PRO WAS NOT CRIMPED ON THE BALLOON, BUT INSTEAD WAS ON THE BALLOON SHAFT. ADDITIONAL STENT (UNKNOWN) WAS OPENED TO COMPLETE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS OPENED ON STERILE TABLE. THE SENT WAS NOT MANIPULATED DURING PREP, THE STENT WAS NOT PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THE ISSUE WAS NOTICED UPON OPENING THE PACKAGE AND THE DEVICE WAS NOT PREPPED. THE OPERATOR WAS A TRAINED USER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042561 ↗
• MalfunctionMar 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE PHYSICIAN WANTED TO USE AN 8MM X 30MM X 29MM 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT HOWEVER, WHEN THE NURSE OPENED THE PACKAGING, THE STENT WAS DETACHED FROM THE BALLOON. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER PALMAZ GENESIS STENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THERE WERE NO DIFFICULTY REMOVING THE DEVICE FROM ITS PACKAGING. THE NURSE TOOK THE SHAFT FROM THE HUB TO PULL OUT FROM ITS PACKAGING. THE DEVICE WAS NOT USED SINCE THE STENT WAS NOT MOUNTED ON THE BALLOON. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862945 ↗
• MalfunctionDec 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE 30MM X 80CM X 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT DELIVERY SYSTEM (SDS) WAS NOT MOUNTED ON THE BALLOON WHEN THE PHYSICIAN OPENED THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY SINCE IT WAS NOT CLINICALLY USED IN THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481039 ↗
• InjuryApr 14, 2017Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PALMAZ GENESIS STENT DETACHED FROM THE BALLOON IN THE PATIENT. THE PHYSICIAN DECIDED TO USE THE SAME BALLOON AND DEPLOY THE STENT IN THE ARTERY AT THAT LOCATION. THE SIZING WASN'T IDEAL BUT IT WAS STILL DEPLOYED FINE. ANOTHER UNKNOWN STENT WAS USED TO COMPLETE THE "KISSING" PROCEDURE. THERE WAS NO PATIENT INJURY AS THE PATIENT IS HEALTHY AND HAD NO IMPACT BECAUSE OF THIS EVEN. THE PHYSICIAN WAS PERFORMING A CASE ON A (B)(6) YEAR OLD LADY AND WAS ATTEMPTING A "KISSING" IN THE ILIACS USING 2 PALMAZ GENESIS. THE ARTERIES WERE VERY "SICK" AND CALCIFIED. WHEN HE TRIED TO REPOSITION ONE OF THE PALMAZ STENT, HE PULLED BACK ONE PALMAZ TOWARDS HIM. THE PALMAZ TOUCHED THE DISTAL END OF THE SHEATH ACCORDING TO HIM. IT WAS HARD TO REMOVE AS THE ARTERY WASN'T "PRETTY" AND IT FELT LIKE IT WAS "SCRATCHING" SOMETHING. HE KEPT PULLING AND THE STENT DETACHED. THE PHYSICIAN WAS WONDERING WHY THE STENT HAD DETACHED FROM THE BALLOON AND STATED THAT HE HAS PERFORMED THIS TYPE OF PROCEDURES MULTIPLE TIMES WHICH THIS KIND OF EVENT HAS NEVER HAPPENED. HE HAS BEEN USING OUR PALMAZ GENESIS STENT SINCE (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494797 ↗
• InjuryApr 14, 2017Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PALMAZ GENESIS STENT DETACHED FROM THE BALLOON IN THE PATIENT. THE PHYSICIAN DECIDED TO USE THE SAME BALLOON AND DEPLOY THE STENT IN THE ARTERY AT THAT LOCATION. THE SIZING WASN'T IDEAL BUT IT WAS STILL DEPLOYED FINE. ANOTHER UNKNOWN STENT WAS USED TO COMPLETE THE "KISSING" PROCEDURE. THERE WAS NO PATIENT INJURY AS THE PATIENT IS HEALTHY AND HAD NO IMPACT BECAUSE OF THIS EVEN. THE PHYSICIAN WAS PERFORMING A CASE ON A (B)(6) LADY AND WAS ATTEMPTING A "KISSING" IN THE ILIACS USING 2 PALMAZ GENESIS. THE ARTERIES WERE VERY "SICK" AND CALCIFIED. WHEN HE TRIED TO REPOSITION ONE OF THE PALMAZ STENT HE PULLED BACK ONE PALMAZ TOWARDS HIM. THE PALMAZ TOUCHED THE DISTAL END OF THE SHEATH ACCORDING TO HIM. IT WAS HARD TO REMOVE AS THE ARTERY WASN'T "PRETTY" AND IT FELT LIKE IT WAS "SCRATCHING" SOMETHING. HE KEPT PULLING AND THE STENT DETACHED. THE PHYSICIAN WAS WONDERING WHY THE STENT HAD DETACHED FROM THE BALLOON AND STATED THAT HE HAS PERFORMED THIS TYPE OF PROCEDURES MULTIPLE TIMES WHICH THIS KIND OF EVENT HAS NEVER HAPPENED. HE HAS BEEN USING OUR PALMAZ GENESIS STENT SINCE (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494765 ↗

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.