LifeStent® Vascular & Biliary Stent EX070803CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® Vascular and Biliary Stent System 7 mm x 80 mm (130 cm delivery catheter) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519001265), received between May 16, 2017 and Nov 14, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
- Fracture1
- Obstruction of Flow1
- Occlusion Within Device1
Patient problems
- No Consequences Or Impact To Patient2
- Stenosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT AFTER SUCCESSFULLY DEPLOYING A VASCULAR STENT, AS THE DELIVERY SYSTEM WAS BEING REMOVED A PORTION OF THE CATHETER ALLEGEDLY DETACHED AND REMAINED ON THE GUIDE WIRE. REPORTEDLY, THE GUIDE WIRE WAS REMOVED WITH THE DETACHED PORTION ATTACHED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7030410 ↗InjuryMay 16, 2017Fracture; Occlusion Within Device; Obstruction of Flow; Fracture; Occlusion Within Device; Obstruction of Flow
IT WAS REPORTED THAT 13 MONTHS POST PTA AND PLACEMENT OF TWO STENTS IN OVERLAPPING TECHNIQUE IN THE PROXIMAL 1/3 OF THE SFA FOR TREATMENT OF A 100 % STENOSIS OF 240 MM LENGTH, AN IN-STENT RESTENOSIS WAS DETECTED. REVASCULARIZATION WAS PERFORMED FOR PATIENT TREATMENT. ADDITIONALLY, DURING A 12 MONTHS FOLLOW UP, A STENT FRACTURE WAS REPORTED. HOWEVER, NO ADDITIONAL TREATMENT WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient; Stenosis
MAUDE report 6569289 ↗
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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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