WALLSTENT® Endoprosthesis H965403110Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent · Class 3 · Implant
All models of WALLSTENT Endoprosthesis (18)
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 08714729203995), received between Dec 11, 2018 and Mar 3, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Activation 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
- Activation Failure1
- Activation, Positioning or Separation Problem1
- Stretched1
Patient problems
- Complaint, Ill-Defined1
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT STENT DID NOT FULLY EXPAND POST DEPLOYMENT. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X40/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER DEPLOYMENT, THE STENT HEAD WAS FOUND NOT FULLY OPENED OR THE PROXIMAL END WAS STILL CLOSED. THE PHYSICIAN DEPLOYED A NON-BSC STENT TO SUPPORT THE ORIGINAL ONE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9780153 ↗InjuryDec 11, 2018Stretched; Activation Failure; Stretched; Activation Failure
IT WAS REPORTED THAT THE STENT FAILED TO FULLY OPEN AND THE PATIENT EXPERIENCED PAIN. THE 14MM DIAMETER TARGET LESION WAS LOCATED IN THE RENAL VEIN. AFTER THE 260CM AMPLATZ WAS PASSED THROUGH, A 14X40/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS USED FOR TREATMENT. HOWEVER, THE STENT FAILED TO FULLY EXPAND AND THEN BECAME TOO LONG TO TOUCH THE INFERIOR VENA CAVA (IVC). THE PATIENT BEGAN TO FEEL PAIN. WHEN THE PHYSICIAN LOOKED AT THE IMAGE, HE FOUND OUT THAT THE AORTA AND THE SUPERIOR MESENTERIC ARTERY WERE OPPRESSED AND THOUGHT IT MIGHT HAVE CAUSED THE WALLSTENT TO NOT TO FULLY EXPAND. THE PHYSICIAN WORRIED ABOUT IVC RUPTURE. THE PATIENT WAS ARRANGED FOR PROLONGED HOSPITALIZATION AND OBSERVATION.
Patient problems: Complaint, Ill-Defined; Pain
MAUDE report 8153284 ↗
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.
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