CP Stent™ 614371Recalls & reported problems
B Braun Interventional Systems, Inc · CMCP022 Mounted Covered CP Stent 3.9 24 · Class 3 · Implant
Data updated Oct 13, 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 04046964899515), received between Mar 11, 2021 and Mar 11, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Advance1
- Improper or Incorrect Procedure or Method1
- Malposition of Device1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2021Improper or Incorrect Procedure or Method; Malposition of Device; Difficult to Advance; Material Split, Cut or Torn
AS PER THE REPORT FROM THE DISTRIBUTOR / USER FACILITY - 14 FR D'VILL SHEATH IN RVOT, LUNDERQUIST WIRE, DIFFICULTY PASSING THE BALLOON STENT COMBO THOUGH THE CHECK FLOW VALVE, WITHOUT PROTECTOR. BEFORE THE STENT BALLOON COMBO EXITED THE DISTAL END OF THE SHEATH, A MAL-POSITION OF THE STENT ON THE BALLOON WAS NOTED. THE STENT BALLOON COMBO WAS REMOVED FROM THE SHEATH UNEVENTFULLY, ALTHOUGH A SLIGHT DAMAGE GORETEX ON THE DISTAL END OF THE STENT WAS NOTED. ON THE BACK TABLE THE BALLOON USED TO EXPAND THE STENT RESULTED IN FURTHER TEAR OF GORETEX WITH ONLY ABOUT 1/3 OF THE STENT COVERED AFTER EXPANSION. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR WAS CONDUIT REHABILITATION PRIOR TO TPVR. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS NOT USED. THERE WAS AN ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE. NEITHER BALLOON WAS INFLATED IN THE PATIENT, ON THE BACK TABLE THE INNER WAS INFLATED FIRST. THE CATHETER SHAFT WAS NOT KINKED.
Patient problems: Insufficient Information
MAUDE report 11466588 ↗
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™ 614308B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614309B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614310B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614376B Braun Interventional Systems, Inc · Aortic stent2 reports
- Minima Stent System - 8mm FG-0002Renata Medical, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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