PALMAZ Balloon Expandable Stent P294Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032064736), received between Jun 3, 2021 and Jun 16, 2021 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2021Migration; Migration

  ACCORDING TO THE LITERATURE ARTICLE BY SLONIM, S. M., DAKE, M. D., RAZAVI, M. K., KEE, S. T., SAMUELS, S. L., RHEE, J. S., & SEMBA, C. P. (1999). MANAGEMENT OF MISPLACED OR MIGRATED ENDOVASCULAR STENTS. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY : JVIR, 10(7), 851¿859. HTTPS://DOI.ORG/10.1016/S1051-0443(99)70127-2, A PALMAZ P294 STENT WAS INTENDED TO BE PLACED IN THE LEFT COMMON CAROTID ARTERY (L CCA) BUT MIGRATED TO THE AORTA DUE TO IT DISLODGING FROM AN UNKNOWN BALLOON. THE STENT WAS REPOSITIONED IN THE RIGHT COMMON ILIAC ARTERY (R CIA) PERCUTANEOUSLY WITH ANOTHER UNKNOWN 3-5MM BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009651 ↗
• InjuryJun 3, 2021Therapy Delivered to Incorrect Body Area; Unintended Movement; Therapy Delivered to Incorrect Body Area; Unintended Movement

  ACCORDING TO THE LITERATURE ARTICLE BY SLONIM, S. M., DAKE, M. D., RAZAVI, M. K., KEE, S. T., SAMUELS, S. L., RHEE, J. S., & SEMBA, C. P. (1999). MANAGEMENT OF MISPLACED OR MIGRATED ENDOVASCULAR STENTS. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY : JVIR, 10(7), 851¿859. HTTPS://DOI.ORG/10.1016/S1051-0443(99)70127-2, A PALMAZ P294 STENT WAS PLACED IN AN UPPER EXTREMITY VEIN AT ANOTHER INSTITUTION AND AFTER REFERRAL, IT WAS FOUND THAT THE STENT MIGRATED TO THE RIGHT PULMONARY ARTERY (RPA) DUE TO IT BEING PRESUMED TO BE TOO SMALL. THE STENT WAS REPOSITIONED IN THE LEFT EXTERNAL ILIAC VEIN (L EIV) PERCUTANEOUSLY WITH ANOTHER UNKNOWN 3-5MM BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11928352 ↗