PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG1910BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032038666), received between Mar 3, 2017 and Feb 19, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2019Inflation Problem; Device Dislodged or Dislocated; Inflation Problem; Device Dislodged or Dislocated

  AS REPORTED, THE GENESIS LONG STENT DEPLOYMENT SYSTEM WOULD NOT INFLATE TO DEPLOY THE MOUNTED STENT AND THE STENT DISLODGED IN THE PATIENT. THERE WAS NO PATIENT INJURY. ANOTHER UNKNOWN BALLOON WAS USED TO DEPLOY THE STENT AS THE STENT REMAINED AT THE TARGET LESION AFTER IT DISLODGED. THE BALLOON LUMEN OF THE GENESIS LONG WOULD NOT WORK AS THERE WAS A BLOCKED. THEREFORE, THE BALLOON AND/OR THE STENT THAT WAS MOUNTED ON IT, COULD NOT BE INFLATED. WHICH RESULTED IN THE STENT DISMOUNTED PREMATURELY. THE OPERATOR HAD TO USE ANOTHER BALLOON TO INFLATE THE STENT IN THE VESSEL WHICH FORTUNATELY REMAINED AT ITS TARGET LOCATION AND DIDN¿T MOVE OR EMBOLIZED. ONCE THE CATHETER WAS REMOVED FROM THE BODY, THE OPERATOR TRIED TO INFLATE THE BALLOON AGAIN TO FIGURE OUT THE ISSUE. THE WIRE LUMEN OF THE CATHETER WAS OKAY. THE BALLOON LUMEN OF THE CATHETER WOULD NOT FUNCTION, IT WOULD NOT INFLATE AT ALL. BLOCKED BY SOMETHING, PREVENTING THE BALLOON TO INFLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8349721 ↗
• InjuryMar 3, 2017Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  AS REPORTED BY THE CUSTOMER VIA TELEPHONE, THE PALMAZ GENESIS PRO WAS INFLATED BUT THE BALLOON COULD NOT EXPAND NOR THE STENT COULDN'T BE DEPLOYED. THERE WAS DIFFICULTY WITHDRAWING THE SYSTEM OUT OF THE PATIENT AND THE STENT DISLODGED FROM THE BALLOON INTO THE PATIENT WHILE WITHDRAWING. SNARING WAS NECESSARY TO RETRIEVE THE STENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6378237 ↗

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.