WALLSTENT™ RP Endoprosthesis M001712060Recalls & 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 08714729345640), received between Aug 28, 2020 and Aug 28, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED SHUNT. A 6X59X75/ ILIAC 6F UNISTEP PLUS REDUCED PROFILE WALLSTENT WAS SELECTED FOR USE. HOWEVER, AFTER DEPLOYING THE STENT, THE SYSTEM WAS CAUGHT ON THE MOST BENT PART OF THE STENT AND COULD NOT BE REMOVED. IT WAS REPEATEDLY PUSHED AND PULLED FOR SEVERAL TIMES AND WAS REMOVED AFTER CHANGING THE ANGLE DIRECTLY ABOVE THE SKIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10465461 ↗
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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