CP Stent™ 614380Recalls & reported problems
B Braun Interventional Systems, Inc · CMCP031 Mounted Covered CP Stent 4.5 18 · 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 04046964899607), received between Jul 19, 2017 and Jul 19, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2017Material Integrity Problem
AS PER THE REPORT FROM BIS "PHYSICIAN STATED THAT THE COVERING WAS NOT RIGHT ON THIS ITEM AND THE STENT WOULD NOT FO INTO THE INTRODUCER PROPERLY." ADDITIONAL INFORMATION FROM BIS WAS SENT ON 7/11/2017. "IN AN EMAIL FROM THE ACCOUNT: PHYSICIAN USED SALINE DURING PREP. THE HEMOSTASIS TOOLS PROVIDED BY NUMED WERE NOT USED. A 14FR MULLINS SHEATH WAS USED. THE COVERING NEVER ENTERED THE INTRODUCER OR THE PATIENT. THE COVERING WAS VERY LOOSE ON THE DISTAL TIP - NOT RIGHT. REGARDING THE INTRODUCER - THE STENT WOULD NOT GO IN - THUS IT WAS NOT PROPER."
Patient problems: No Patient Involvement
MAUDE report 6725904 ↗
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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