PALMAZ Balloon Expandable Stent P154Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032076234), received between Jun 3, 2021 and Jun 9, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2021Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  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 P154 STENT WAS INTENDED TO BE PLACED IN THE LEFT RENAL ARTERY (LRA) BUT MIGRATED TO THE AORTA DUE TO IT GETTING CAUGHT ON AN UNKNOWN CATHETER. 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 11970334 ↗
• InjuryJun 8, 2021Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  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 P154 STENT WAS INTENDED TO BE PLACED IN THE RIGHT RENAL ARTERY (RRA) BUT MIGRATED TO THE AORTA DUE TO IT DISLODGING FROM AN UNKNOWN BALLOON. THE STENT WAS REPOSITIONED IN LEFT EXTERNAL ILIAC ARTERY (L EIA) 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 11962108 ↗
• InjuryJun 8, 2021Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  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), 851859. HTTPS://DOI.ORG/10.1016/S1051-0443(99)70127-2, A PALMAZ P154 STENT WAS INTENDED TO BE PLACED IN THE RIGHT COMMON ILIAC ARTERY (R CIA) BUT MIGRATED TO THE AORTA DUE TO IT DISLODGING FROM AN UNKNOWN BALLOON. THE STENT WAS REPOSITIONED IN THE LEFT COMMON ILIAC ARTERY (L 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 11960863 ↗
• InjuryJun 8, 2021Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  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 15MM P154 STENT WAS INTENDED TO BE PLACED IN THE RIGHT RENAL ARTERY BUT MIGRATED TO THE AORTA DUE TO IT DISLODGING FROM AN UNKNOWN BALLOON. THE STENT REMAINED ON THE UNKNOWN 0.035¿ GUIDEWIRE. THE STENT WAS REPOSITIONED IN THE LEFT EXTERNAL ILIAC ARTERY (L EIA) 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 11954477 ↗
• InjuryJun 3, 2021Unintended Movement; 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 P154 STENT WAS INTENDED TO BE PLACED IN THE AXILLARY VEIN BUT MIGRATED TO THE RIGHT VENTRICLE DUE TO IT BEING TOO SMALL. PERCUTANEOUS RETRIEVAL WAS UNSUCCESSFUL DUE TO THE PATIENT DEVELOPING CHEST PAIN WHEN TRACTION WAS PLACED ON A SNARE PASSED AROUND THE STENT. THE STENT HAD TO BE SURGICALLY REMOVED FROM THE HEART AND AT SURGERY, THE STENT WAS FOUND TO BE ENTANGLED IN THE TRICUSPID VALVE. THE PATIENT DEVELOPED TRICUSPID REGURGITATION AFTER ATTEMPTED STENT RETRIEVAL, WHICH MAY HAVE BEEN CAUSED BY MANIPULATION OF THE STENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11928390 ↗