PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG1550BPSRecalls & reported problems
Cordis Corporation · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032037447), received between May 2, 2017 and May 2, 2017 — 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
Device problems
- Device Dislodged or Dislocated1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE STENT DISLODGED FROM THE GENESIS ON PRO BALLOON CATHETER WHILE BEING PLACED IN POSITION AT THE OSTIAL LESION OF THE CELIAC ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE STENT WITH A SNARE AND THE PROCEDURE WAS ABORTED. THERE WAS SLIGHT DIFFICULTY ADVANCING THE DEVICE TOWARDS THE LESION. THERE WAS NO PATIENT INJURY. THERE WAS SIGNIFICANT CALCIUM AT THE OSTIUM LESION. THE PRODUCT WILL BE SENT FOR EVALUATION. THE DEVICE PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO DIFFICULTY OR DEFECT NOTED. THERE WAS NO EXCESSIVE FORCED USED ANYTIME DURING THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6538924 ↗
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, ClassifiedPALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Other CATHETER, BILIARY, DIAGNOSTIC devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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