PALMAZ Balloon Expandable Stent P204Recalls & reported problems
Cordis US Corp. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032076197), received between Jun 8, 2021 and Jun 8, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
Device problems
- Device Dislodged or Dislocated2
- Therapy Delivered to Incorrect Body Area2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 P204 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 THE LEFT SUBCLAVIAN ARTERY (L SCA) 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 11960819 ↗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 P204 STENT WAS INTENDED TO BE PLACED IN THE LEFT SUBCLAVIAN ARTERY (L SCA) BUT MIGRATED TO THE AORTA DUE TO IT GETTING CAUGHT ON AN UNKNOWN CATHETER. 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 11954496 ↗
Other STENT, CORONARY devices
- WALLSTENT® Endoprosthesis H965403130Boston Scientific Corporation · STENT, CORONARY35 reports
- WALLSTENT® Endoprosthesis H965402130Boston Scientific Corporation · STENT, CORONARY23 reports
- Tryton Side Branch Stent T5-2530-191-USTryton Medical, Inc. · Stent, Coronary1 death22 reports
- WALLSTENT® Endoprosthesis H965403330Boston Scientific Corporation · STENT, CORONARY21 reports
- WALLSTENT® Endoprosthesis H965403320Boston Scientific Corporation · STENT, CORONARY10 reports
- WALLSTENT® Endoprosthesis H965403120Boston Scientific Corporation · STENT, CORONARY9 reports
- Tryton Side Branch Stent T5-3035-151-USTryton Medical, Inc. · Stent, Coronary2 deaths7 reports
- MULTI-LINK VISION 1007850-15Abbott Vascular Inc. · STENT, CORONARY7 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page