PALMAZ Balloon Expandable Stent P308Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032057292), received between Apr 30, 2021 and Jul 13, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2021Migration; Migration

  AS REPORTED IN THE LITERATURE ARTICLE BY PRISCHL, F. C., WEBER, T., LENGLINGER, F., KIRCHGATTERER, A., WALLNER, M., & KRAMAR, R. (1997). CONSERVATIVE MANAGEMENT OF LATE PALMAZ STENT EMBOLIZATION TO THE PULMONARY ARTERY--A COMPLICATION AFTER PTA WITH STENT IMPLANTATION OF A FISTULA-DRAINING RIGHT SUBCLAVIAN VEIN STENOSIS. NEPHROLOGY, DIALYSIS, TRANSPLANTATION : OFFICIAL PUBLICATION OF THE EUROPEAN DIALYSIS AND TRANSPLANT ASSOCIATION - EUROPEAN RENAL ASSOCIATION, 12(9), 1994¿1996. HTTPS://DOI.ORG/10.1093/NDT/12.9.1994, SIX WEEKS AFTER IMPLANTATION OF A PALMAZ P308 8-12MM STENT, THE STENT EMBOLIZED TO THE PULMONARY ARTERY (PA). THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF A RIGHT SUBCLAVIAN VEIN STENOSIS. APPROXIMATELY 46 DAYS AFTER IMPLANTATION, THE PATIENT REPORTED DISCOMFORT AND CHEST PAIN FOR THE PAST 3 DAYS. A CHEST XRAY REVEALED THE PALMAZ STENT HAD EMBOLIZED FROM THE RIGHT SUBCLAVIAN VEIN TO THE LEFT LOWER PA. PERFUSION SCANS SHOWED NO SIGNS OF PULMONARY EMBOLISM (PE) OR OCCLUSION OF THE PA. PATIENT WAS TREATED WITH A CONSERVATIVE APPROACH INSTEAD OF SURGERY. THE PATIENT WAS DIALYZED AS USUAL, INCLUDING THERAPEUTIC ANTICOAGULATION. HEPARIN WAS CONTINUED AF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160575 ↗
• InjuryJun 14, 2021Device Dislodged or Dislocated; 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 P308 STENT WAS INTENDED TO BE PLACED IN THE LEFT COMMON ILIAC VEIN (L CIV) BUT MIGRATED TO THE INFERIOR VENA CAVA (IVC) DUE TO RUPTURE OF AN UNKNOWN BALLOON. THE STENT WAS REMOVED 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 11991631 ↗
• InjuryJun 14, 2021Therapy Delivered to Incorrect Body Area; Migration; Therapy Delivered to Incorrect Body Area; 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 P308 STENT AND A PALMAZ P394 STENT WERE INTENDED TO BE PLACED IN THE SUPERIOR VENA CAVA (SVC) BUT MIGRATED TO THE RIGHT COMMON ILIAC VEIN (R CIV) DUE TO BOTH STENTS BEING TOO SMALL. THE PALMAZ P308 STENT WAS REPOSITIONED IN THE RIGHT COMMON ILIAC VEIN (R CIV) PERCUTANEOUSLY WITH ANOTHER UNKNOWN 3-5MM BALLOON CATHETER. THE PALMAZ P394 WAS REPOSITIONED IN THE LEFT EXTERNAL ILIAC VEIN (L EIV) PERCUTANEOUSLY WITH ANOTHER UNKNOWN 3-5MM BALLOON CATHETER. BECAUSE THE PALMAZ P394 DID NOT OPPOSE THE WALLS OF THE VEIN, ANOTHER NON CORDIS 24MM STENT WAS USED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11990242 ↗
• InjuryJun 8, 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 P308 STENT WAS INTENDED TO BE PLACED IN THE HEPATIC INFERIOR VENA CAVA (IVC) BUT MIGRATED TO THE RENAL IVC DUE TO RUPTURE OF THE UNKNOWN BALLOON. THE STENT WAS REPOSITIONED IN THE IVC 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 11959687 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE LITERATURE ARTICLE BY ,LAW, M. A., SHAMSZAD, P., NUGENT, A. W., JUSTINO, H., BREINHOLT, J. P., MULLINS, C. E., & ING, F. F. (2010). PULMONARY ARTERY STENTS: LONG-TERM FOLLOW-UP. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS : OFFICIAL JOURNAL OF THE SOCIETY FOR CARDIAC ANGIOGRAPHY & INTERVENTIONS, 75(5), 757¿764. HTTPS://DOI.ORG/10.1002/CCD.22356, TWO PALMAZ 3 SERIES IN ONE PATIENT P308 STENTS DEVELOPED HEMODYNAMICALLY SIGNIFICANT RESTENOSIS. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Restenosis

  MAUDE report 11784131 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE LITERATURE ARTICLE BY ,LAW, M. A., SHAMSZAD, P., NUGENT, A. W., JUSTINO, H., BREINHOLT, J. P., MULLINS, C. E., & ING, F. F. (2010). PULMONARY ARTERY STENTS: LONG-TERM FOLLOW-UP. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS : OFFICIAL JOURNAL OF THE SOCIETY FOR CARDIAC ANGIOGRAPHY & INTERVENTIONS, 75(5), 757¿764. HTTPS://DOI.ORG/10.1002/CCD.22356, TWO PALMAZ 3 SERIES IN ONE PATIENT P308 STENTS DEVELOPED HEMODYNAMICALLY SIGNIFICANT RESTENOSIS.

  Patient problems: Restenosis

  MAUDE report 11784116 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE LITERATURE ARTICLE BY ,LAW, M. A., SHAMSZAD, P., NUGENT, A. W., JUSTINO, H., BREINHOLT, J. P., MULLINS, C. E., & ING, F. F. (2010). PULMONARY ARTERY STENTS: LONG-TERM FOLLOW-UP. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS : OFFICIAL JOURNAL OF THE SOCIETY FOR CARDIAC ANGIOGRAPHY & INTERVENTIONS, 75(5), 757¿764. HTTPS://DOI.ORG/10.1002/CCD.22356, ONE PATIENT WITH A PALMAZ 3 SERIES P308 STENT DEVELOPED HEMODYNAMICALLY SIGNIFICANT RESTENOSIS.

  Patient problems: Restenosis

  MAUDE report 11753847 ↗