CP Stent™ 614363Recalls & reported problems
B Braun Interventional Systems, Inc · CMCP014 Mounted Covered CP Stent 3.4 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 04046964899430), received between Oct 7, 2019 and Oct 7, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionOct 7, 2019Detachment of Device or Device Component
AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - COVERED MOUNTED CP STENT COVERING CAME OFF WHEN INSERTING INTO THE D'VILL SHEATH. IT NEVER MADE IT INTO PATIENT. UPDATE 9/10/2019 - IN AN EMAIL FROM THE ACCOUNT: THE D'VILL WAS 14FR X 85CM CATALOG # 612845 LOT #: DV-0145 ST-1203; GUIDEWIRE USED WAS A .035 X 260CM LUNDERQUIST WIRE MADE BY COOK MEDICAL; PHYSICIAN DID NOT USE THE BLUE INSERTION TOOL, BUT DID CUT OFF THE END OF A TERUMO SHEATH TO USE AS AN INSERTION TOOL, WHICH WAS NOT SAVED; PHYSICIAN DID MANUALLY CRIMP THE STENT OUT OF THE PACKAGE BEFORE INSERTING INTO THE SHEATH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9162941 ↗
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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