Palmaz Genesis PG3910BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032057544), received between Jan 2, 2018 and Jan 2, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2018Defective Component; Physical Resistance; Device Dislodged or Dislocated; Defective Component; Physical Resistance; Device Dislodged or Dislocated

  DURING USE IN PATIENT, IT WAS REPORTED THAT A PALMAZ STENT WAS MOUNTED ON A NON CORDIS BALLOON CATHETER AND AN ATTEMPT WAS MADE TO ADVANCE THE DEVICES THROUGH A 8F NON CORDIS SHEATH. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN FORCE THE DEVICE THROUGH THE SHEATH AND THE STENT WAS PROXIMAL TO THE BALLOON AND IT WAS IMPOSSIBLE TO DILATE IT. THE PHYSICIAN TRIED TO PASS A SMALLER 0.035" BALLOON THROUGH THE STENT INSIDE THE PATIENT, BUT HE WAS ONLY PUSHING IT UPWARDS. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN TRIED TO SNARE THE STENT AND REMOVE IT FROM THE PATIENT. DURING THIS MANEUVER, THE STENT DROPPED AND LANDED IN THE POPLITEAL ARTERY. THE PROCEDURE WAS COMPLETED USING A NON CORDIS 10 X 40 MM STENT BY OVER EXPANDING IT TO 12 MM. THE STENT COULDN¿T BE REMOVED AND THE PATIENT HAD TO BE HOSPITALIZED WHILE HE NEEDED A SURGICAL REMOVAL OF THE STENT. THE PHYSICIAN COMPLAINS ABOUT THE LABELING, THAT NOWHERE THE SHEATH FITTING OF THE STENT WAS WRITTEN ON THE LABEL. HE DOUBTS THAT THIS STENT PASSES 8F, AS HE HAD TO FORCE HARDLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7157986 ↗