WALLSTENT™ RP Endoprosthesis M001712000Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent · Class 3
All models of WALLSTENT RP Endoprosthesis (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729345589), received between Jun 29, 2022 and Jun 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2022Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09-JUN-2022. IT WAS REPORTED THAT STENT DEPLOYMENT ISSUES OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A THIN SHUNT OF THE FOREARM VEIN. A 4-40 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. A NON- BOSTON SCIENTIFIC BALLOON CATHETER WAS ADVANCED AND DILATATION WAS PERFORMED. SUBSEQUENTLY, A 6X24X75CM WALLSTENT RP ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE OUTER SHAFT WAS TOO HARD TO PULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER 7-23 WALLSTENT. THERE WERE NO PATIENT INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14851834 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Absolute Pro 1012536-100Abbott Vascular Inc. · STENT, ILIAC21 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.
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