WALLSTENT™ RP Endoprosthesis M001712380Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729345923), received between Oct 2, 2017 and Mar 23, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Markings/Labelling Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2020. A 10X69X75/ ILIAC 6F UNISTEP PLUS WALLSTENT RP ENDOPROSTHESIS WAS USED WITH NO KNOWN ISSUES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACHMENT AND SHAFT BREAK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9865591 ↗MalfunctionOct 2, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE PRODUCT WAS MISLABELED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 10X69X75 WALLSTENT¿ RP ENDOPROSTHESIS WAS SELECTED TO TREAT THE LESION. DURING ADVANCING INTO THE INTRODUCER SHEATH, IT WAS NOTED THAT THE STENT WAS FLAWED AS IT WAS MUCH LONGER THAN WHAT WAS LABELED. THE ACTUAL STENT LENGTH MEASURED AT 130MM. THE STENT WAS DEPLOYED AS THERE WAS NO SPARE STENT FOR REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6907507 ↗
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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