Palmaz Genesis PG2510BRecalls & reported problems
Cordis Corporation · STENT GENESIS XD 25MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032057490), received between May 17, 2021 and Aug 17, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Bradycardia1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2021Fracture; Fracture
AS REPORTED, THE PATIENT HAD A STENT FRACTURE AFTER A 25MM UNMOUNTED EXTRA DIAMETER (XD) PALMAZ GENESIS TRANSHEPATIC BILIARY STENT WAS PLACED. THE BILIARY STENT WAS BROKEN IN THE PULMONARY ARTERY AND A LARGER STENT WAS ADDED LATER. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12330674 ↗InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED IN THE LITERATURE ARTICLE BY FEINSTEIN, J. A., KIM, N., REDDY, V. M., & PERRY, S. B. (2006). PERCUTANEOUS PULMONARY VALVE PLACEMENT IN A (B)(6)-MONTH-OLD PATIENT USING A HAND CRAFTED STENT-MOUNTED PORCINE VALVE. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS : OFFICIAL JOURNAL OF THE SOCIETY FOR CARDIAC ANGIOGRAPHY & INTERVENTIONS, 67(4), 644¿649. HTTPS://DOI.ORG/10.1002/CCD.20668, FOLLOWING THE INITIAL STENT DEPLOYMENT OF A PALMAZ GENESIS 2510B STENT ON A SUTURED NON CORDIS PORCINE VALVE, THERE WAS A BRIEF PERIOD OF BRADYCARDIA WITH ST SEGMENT AND ST-T WAVE CHANGES THAT RESPONDED TO ATROPINE AND EPINEPHRINE. THE PATIENT WAS EXTUBATED THE NEXT DAY AND WAS DISCHARGED FROM THE HOSPITAL SIX DAYS AFTER THE PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: Bradycardia
MAUDE report 11831096 ↗
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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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