LIFESTENTRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 0
We found 28 models of LIFESTENT by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2018 and Sep 28, 2026 — classified as 29 injuries, 112 malfunctions.
The most frequently reported specific device problem is “Break” (80 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LIFESTENT problems
Device problems
- Break80
- Detachment of Device or Device Component55
- Material Deformation29
- Difficult to Remove21
- Fracture16
- Positioning Failure16
- Misfire11
- Malposition of Device9
Patient problems
- No Clinical Signs, Symptoms or Conditions84
- No Consequences Or Impact To Patient25
- Foreign Body In Patient14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Insufficient Information5
- Device Embedded In Tissue or Plaque2
- Injury2
- Stenosis2
LIFESTENT models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LIFESTENT® 5F061503CSSTENT, SUPERFICIAL FEMORAL ARTERY22 reports
- LIFESTENT® 5F070403CSSTENT, SUPERFICIAL FEMORAL ARTERY12 reports
- LIFESTENT® 5F061003CSSTENT, SUPERFICIAL FEMORAL ARTERY10 reports
- LIFESTENT® 5F051003CSSTENT, SUPERFICIAL FEMORAL ARTERY10 reports
- LIFESTENT® 5F071003CSSTENT, SUPERFICIAL FEMORAL ARTERY9 reports
- LIFESTENT® 5F051503CSSTENT, SUPERFICIAL FEMORAL ARTERY9 reports
- LIFESTENT® 5F051703CSSTENT, SUPERFICIAL FEMORAL ARTERY8 reports
- LIFESTENT® 5F060403CSSTENT, SUPERFICIAL FEMORAL ARTERY7 reports
- LIFESTENT® 5F050803CSSTENT, SUPERFICIAL FEMORAL ARTERY7 reports
- LIFESTENT® 5F060603CSSTENT, SUPERFICIAL FEMORAL ARTERY5 reports
- LIFESTENT® 5F061203CSSTENT, SUPERFICIAL FEMORAL ARTERY5 reports
- LIFESTENT® 5F050603CSSTENT, SUPERFICIAL FEMORAL ARTERY5 reports
- LIFESTENT® 5F060803CSSTENT, SUPERFICIAL FEMORAL ARTERY4 reports
- LIFESTENT® 5F061501CSSTENT, SUPERFICIAL FEMORAL ARTERY4 reports
- LIFESTENT® 5F070603CSSTENT, SUPERFICIAL FEMORAL ARTERY3 reports
- LIFESTENT® 5F070803CSSTENT, SUPERFICIAL FEMORAL ARTERY3 reports
- LIFESTENT® 5F070601CSSTENT, SUPERFICIAL FEMORAL ARTERY2 reports
- LIFESTENT® 5F070303CSSTENT, SUPERFICIAL FEMORAL ARTERY2 reports
- LIFESTENT® 5F071203CSSTENT, SUPERFICIAL FEMORAL ARTERY2 reports
- LIFESTENT® 5F050403CSSTENT, SUPERFICIAL FEMORAL ARTERY2 reports
- LIFESTENT® 5F051203CSSTENT, SUPERFICIAL FEMORAL ARTERY2 reports
- LIFESTENT® 5F060303CSSTENT, SUPERFICIAL FEMORAL ARTERY2 reports
- LIFESTENT® 5F070301CSSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- LIFESTENT® 5F070801CSSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- LIFESTENT® 5F071201CSSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- LIFESTENT® 5F070203CSSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- LIFESTENT® 5F050303CSSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- LIFESTENT® 5F061001CSSTENT, SUPERFICIAL FEMORAL ARTERY1 report
Recent LIFESTENT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Break; Migration or Expulsion of Device; Detachment of Device or Device Component
Patient problems: Foreign Body In Patient
MAUDE report 50914949 ↗MalfunctionJul 27, 2026Break; Detachment of Device or Device Component; Difficult to Advance
On (b)(6)2026, a patient underwent stent placement procedure using a Lifestent device via common femoral artery in the right groin. It was reported that the tip of the delivery catheter broke on the stent and the two hollow outer sheaths broke. It was further reported that the physician tried snaring one of the two pieces which further migrated both distally. One segment parked in a collateral. The other piece was parked with a coronary stent in the profunda which remained patent. However, the current condition of the patient is unknown.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50020952 ↗MalfunctionMay 18, 2026Break; Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT VASCULAR STENT. DURING THE PROCEDURE, THE STENT IS INSERTED, AND THE DEPLOYMENT SYSTEM IS REMOVED. THE LIFESTREAM STENT CATHETER BROKE AFTER DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197775 ↗MalfunctionMay 13, 2026Break; Detachment of Device or Device Component; Difficult to Advance
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTENT DEVICE. IT WAS REPORTED THAT THE NOSE CONE OF THE STENT DETACHED AFTER DEPLOYMENT. THE CATHETER FRAGMENTS WERE SUBSEQUENTLY RETRIEVED FROM THE PATIENT¿S BODY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157848 ↗MalfunctionApr 27, 2026Break; Difficult to Remove; Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTENT. DURING PROCEDURE IN THE COMMON FEMORAL ARTERY, THE STENT TIP BROKE OFF AFTER STENT DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24996804 ↗MalfunctionApr 27, 2026Break; Difficult to Remove; Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTENT. IT WAS REPORTED THAT THE STENT TIP BROKE OFF AFTER STENT DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994434 ↗MalfunctionMar 3, 2026Break; Positioning Failure; Difficult to Remove; Activation Failure
ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE THUMB WHEEL WAS BROKEN, AND THE STENT WOULD NOT DEPLOY. REPORTEDLY, IT GOT STUCK IN THE SHEATH, SO EVERYTHING HAD TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24493277 ↗MalfunctionDec 5, 2025Misfire; Misfire
ON (B)(6) 2025, A PATIENT UNDERWENT STENT GRAFT PLACEMENT PROCEDURE USING LIFE STENT. DURING THE PROCEDURE, THE STENT ALLEGEDLY GOT PARTIALLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23724403 ↗MalfunctionNov 17, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT VASCULAR STENT VIA CONTRALATERAL APPROACH. DURING PROCEDURE, THE STENT DEPLOYED WITH NO ISSUES. WHEN THE DOCTOR WAS REMOVING THE STENT, THE NOSE CONE ON THE DELIVERY SYSTEM BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23566848 ↗MalfunctionNov 11, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure
A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING TWO LIFESTENT DEVICES. ALLEGEDLY 7X100 MM LIFESTENT DID NOT EXPAND TO ITS FULL INTENDED LENGTH AND THERE WERE ALSO DEPLOYMENT CHALLENGES WITH THE SECOND STENT 7X80 MM LIFESTENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23519752 ↗MalfunctionNov 6, 2025Malposition of Device; Material Deformation; Malposition of Device; Material Deformation
ON (B)(6) 2025, A 75-YEAR-OLD PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT GOT FORESHORTENED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484088 ↗MalfunctionNov 3, 2025Material Deformation; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT WITH LIFESTENT VASCULAR STENT. DURING THE PROCEDURE WHEN IT WAS PLACED IN THE PATIENT IT WAS FOUND THAT THE LENGTH OF THE STENT WAS NOT ACCURATE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23447441 ↗MalfunctionOct 27, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT. DURING THE PROCEDURE WHEN PHYSICIAN INTRODUCED THE STENT INTO THE SHEATH 5F VIA SUPERFICIAL FEMORAL ARTERY, IT WAS NOTED THAT RESISTANCE OCCURRED. WHEN THE STENT WAS REMOVED OUT OF THE SHEATH, SELF DEPLOYMENT OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23388271 ↗MalfunctionOct 17, 2025Material Deformation; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT. DURING PROCEDURE IT WAS REPORTED THAT, ALLEGEDLY THE STENT WAS FORESHORTENED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321404 ↗InjurySep 30, 2025Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT 5F, THE STENT DEPLOYED, BUT THE CORE/TIP OF THE DEPLOYMENT SYSTEM DISLODGED INSIDE THE PATIENT. RETRIEVAL ATTEMPTS FAILED, AND THE PATIENT REQUIRED SURGICAL CUTDOWN. THE PATIENT STATUS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 23178039 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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