Palmaz Genesis PG1910BRecalls & reported problems
Cordis US Corp. · STENT GENESIS XD 19MM · 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 20705032057452), received between May 20, 2021 and May 20, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
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.
InjuryMay 20, 2021Migration; Migration
ACCORDING TO THE LITERATURE REVIEW ARTICLE BY KOBAYASHI, D., SINGH, H. R., TURNER, D. R., FORBES, T. J., & GOWDA, S. T. (2012). TRANSCATHETER RETRIEVAL AND REPOSITIONING OF EMBOLIZED STENT FROM THE RIGHT VENTRICLE IN AN INFANT. TEXAS HEART INSTITUTE JOURNAL, 39(5), 639¿643., A PALMAZ GENESIS XD 1910 STENT WAS PLACED ACROSS THE ATRIAL SEPTUM. AFTER STENT DEPLOYMENT, PART OF THE NON CORDIS BALLOON WAS STUCK TO THE DISTAL STENT. THE FOLDING OF THE BALLOON MAY HAVE DISPLACED THE STENT SLIGHTLY TOWARD THE RIGHT ATRIUM. ONE WEEK AFTER IMPLANTATION, THE STENT WAS FOUND TO HAVE EMBOLIZED INTO THE RIGHT VENTRICLE. THE STENT WAS RETRIEVED AND REPOSITIONED VIA TRANSCATHETER TECHNIQUE USING A NON CORDIS 6F CATHETER. NO FURTHER COMPLICATIONS REPORTED. THERE WAS NO EVIDENCE OF VESSEL INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11856989 ↗
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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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