WALLSTENT™ RP Endoprosthesis M001711360Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent · Class 3 · Implant
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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729406471), received between Apr 8, 2019 and Apr 8, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT A STENT MIGRATION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN UNKNOWN ARTERY. A 10X42X75 UNISTEP PLUS STENT SELF EXPANDING WAS ADVANCED FOR TREATMENT HOWEVER IT FORESHORTENED POST DEPLOYMENT. ANOTHER 10X68X75 UNISTEP PLUS STENT SELF EXPANDING WAS DEPLOYED. HOWEVER, AFTER CHECKING THE FLUOROSCOPY, THE STENT MIGRATED TO THE HEART. THE PROCEDURE WAS ENDED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR OPEN HEART SURGERY. THE DEVICES WERE REMOVED BY A CARDIOVASCULAR SURGEON. THE PATIENT STATUS WAS STABLE POST SURGICAL EXPLANT.
Patient problems: No Code Available
MAUDE report 8492572 ↗
Other SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS devices
- GORE VIATORR TIPS Endoprosthesis PTB8108275W. L. Gore & Associates, Inc. · Shunt, Portosystemic, Endoprosthesis15 reports
- GORE VIATORR TIPS Endoprosthesis PTB8106275W. L. Gore & Associates, Inc. · Shunt, Portosystemic, Endoprosthesis5 reports
- GORE VIATORR TIPS Endoprosthesis PTB8107275W. L. Gore & Associates, Inc. · Shunt, Portosystemic, Endoprosthesis3 reports
- WALLSTENT® Endoprosthesis H965402110Boston Scientific Corporation · SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS2 reports
- GORE VIATORR TIPS Endoprosthesis PTB8105275W. L. Gore & Associates, Inc. · Shunt, Portosystemic, Endoprosthesis1 report
- GORE VIATORR TIPS Endoprosthesis PTB8104275W. L. Gore & Associates, Inc. · Shunt, Portosystemic, Endoprosthesis1 report
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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