CP Stent™ 614375Recalls & reported problems
B Braun Interventional Systems, Inc · CMCP026 Mounted Covered CP Stent 4.5 20 · Class 3 · Implant
All models of CP Stent (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964899553), received between Feb 21, 2017 and Feb 21, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 16, 2026.
Most reported problems
Device problems
- Difficult or Delayed Positioning1
- Migration or Expulsion of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2017Difficult or Delayed Positioning; Migration or Expulsion of Device
AS PER THE REPORT FROM BIS: "THE STENT WENT THROUGH THE SHEATH FINE. AFTER UNSHEATHING, IT WAS NOTICED THAT THE STENT WAS MOUNTED DISTALLY BEFORE INFLATION, IT HAD MIGRATED. THE PHYSICIAN WAS ABOUT TO USE THE STENT, IT WAS JUST DIFFICULT TO USE. THE STENT WAS BEING USED FOR A SMALL CONDUIT TEAR. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT WAS FINE POST PROCEDURE. SALINE AND CONTRAST WERE BOTH USED DURING PREP. THE PHYSICIAN DID INFLATE THE INNER BALLOON BEFORE THE OUTER BALLOON, AND DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6347045 ↗
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™ 614516B Braun Interventional Systems, Inc · Aortic stent2 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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