PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2980BPXRecalls & reported problems
Cordis US Corp. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032039724), received between Jul 14, 2023 and Jul 14, 2023 — classified as 1 malfunction.
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 Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED, THE STENT OF A 29 X 80 135CM PALMAZ GENESIS BILIARY ON OPTA PRO STENT DELIVERY SYSTEM (SDS) SLID OFF THE BALLOON BEFORE ENTERING THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DAMAGE TO THE DEVICE PACKAGING PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM ITS STERILE PACKAGING. THE STENT WAS NOT MANIPULATED ON THE DELIVERY SYSTEM AND THE BALLOON WAS NOT INFLATED TO MAINTAIN THE STENT PLACEMENT ON THE DELIVERY SYSTEM. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325621 ↗
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
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- 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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