CP Stent™ 614516Recalls & reported problems
B Braun Interventional Systems, Inc · COVERED CP STENT 8Z 6.0CM · Class 3 · Implant
All models of CP Stent (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046955195190), received between Jul 27, 2022 and Jul 27, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (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 16, 2026.
Most reported problems
Device problems
- Device Handling Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2022Device Handling Problem; Device Handling Problem
AS PER THE INITIAL REPORT FROM THE FOREIGN DISTRIBUTOR / USER FACILITY - "ALL THE STENT THE OUTER COVER WAS FLOPPY AND EASILY PEELABLE. HENCE WE HAD DIFFICULTY AS THE OUTER COVER WOULD MOVE AND THE STENT WORKED AS BARE STENT. THE MOUNTED STENT TOO THE BALLOON WAS ALREADY CRIMPED IE LOOKED LIKE USED BALLON ON WHICH THIS STENT WAS MOUNTED WAS REUSED. DEFINITELY NOT A PREMOUNTED STENT." UNMOUNTED COVERED CP STENTS HAD COVERING ISSUES ACCORDING TO THIS USER FACILITY. WILL BE REPORTED WITH 1318694-2022-00008. BOTH DEVICES WERE USED ON THE SAME PATIENT DURING THE SAME PROCEDURE. A COVERED MOUNTED STENT WAS THEN USED WITH NO REPORTED ISSUES WITH THE COVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15110874 ↗MalfunctionJul 27, 2022Device Handling Problem; Device Handling Problem
AS PER THE INITIAL REPORT FROM THE FOREIGN DISTRIBUTOR / USER FACILITY - "ALL THE STENT THE OUTER COVER WAS FLOPPY AND EASILY PEELABLE. HENCE WE HAD DIFFICULTY AS THE OUTER COVER WOULD MOVE AND THE STENT WORKED AS BARE STENT. THE MOUNTED STENT TOO THE BALLOON WAS ALREADY CRIMPED IE LOOKED LIKE USED BALLON ON WHICH THIS STENT WAS MOUNTED WAS REUSED. DEFINITELY NOT A PREMOUNTED STENT." (2) UNMOUNTED COVERED CP STENTS HAD COVERING ISSUES ACCORDING TO THIS USER FACILITY. WILL BE REPORTED WITH 1318694-2022-00009. BOTH DEVICES WERE USED ON THE SAME PATIENT DURING THE SAME PROCEDURE. A COVERED MOUNTED STENT WAS THEN USED WITH NO REPORTED ISSUES WITH THE COVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15110871 ↗
Other Aortic stent devices
- Minima Stent System - 6mm FG-0001Renata Medical, Inc. · Aortic Stent1 death10 reports
- CP Stent™ 614311B Braun Interventional Systems, Inc · Aortic stent6 reports
- CP Stent™ 614310B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614309B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614308B Braun Interventional Systems, Inc · Aortic stent3 reports
- Minima Stent System - 8mm FG-0002Renata Medical, Inc. · Aortic Stent2 reports
- CP Stent™ 614376B Braun Interventional Systems, Inc · Aortic stent2 reports
- CP Stent™ 614375B Braun Interventional Systems, Inc · Aortic stent1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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