RECOVERY CONE® FBRCRecalls & reported problems
Bard Peripheral Vascular, Inc. · RECOVERY CONE® Removal System · Class 2
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 00801741040948), received between Nov 9, 2016 and Jun 16, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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, 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
- Detachment of Device or Device Component2
- Material Separation2
- Bent1
- Break1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2017Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A FILTER RETRIEVAL PROCEDURE, THE CONE RETRIEVAL DEVICE CAPTURED THE FILTER INTO SHEATH; HOWEVER, UPON REMOVAL OF THE FILTER, THE RETRIEVAL SYSTEM DETACHED. THEREFORE, THE RETRIEVAL DEVICE, FILTER AND SHEATH WERE REMOVED AS A SINGLE UNIT. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6648365 ↗InjuryNov 9, 2016Bent; Material Separation; Detachment of Device or Device Component; Bent; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SCHEDULED RETRIEVAL OF A VENA CAVA FILTER, THE FILTER WAS CAPTURED AND RETRIEVED INTO THE SHEATH; HOWEVER, DURING REMOVAL OF THE RETRIEVAL SYSTEM FROM THE PATIENT, SLIGHT RESISTANCE WAS MET AND THE RADIOPAQUE MARKER BAND ALLEGEDLY DETACHED AND WAS LOCATED IN THE RIGHT ATRIUM AS DEMONSTRATED BY FINAL FLUOROSCOPY. THE MARKER BAND WAS RETRIEVED APPROXIMATELY TWO HOURS AFTER DISCOVERY OF THE DETACHMENT WITH APPROXIMATELY 80 MINUTES OF FLUOROSCOPY. THE PATIENT WAS REPORTEDLY DOING WELL POST PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6089326 ↗
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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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