CP Stent™ 614478Recalls & reported problems
B Braun Interventional Systems, Inc · COVERED CP STENT 10Z 5.5CM · 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 04046955091218), received between Oct 7, 2021 and Oct 7, 2021 — classified as 1 malfunction.
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
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2021No Apparent Adverse Event; No Apparent Adverse Event
AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - AFTER CRIMPING THE COVERED STENT ON A 18MM OD BIB BALLOON - PRIOR TO ADVANCING IN 22MM GORE DRYSEAL SHEATH, THE COVERING WAS NOTED TO BE COMPLETELY OFF THE STENT. IT HAD BEEN SOAKING IN NS WITH HEPARIN SOLUTION 15 MINUTES PRIOR TO CRIMPING. INDICATION THE PHYSICIAN WAS USING THE STENT: SINUS VENOSUS ASD CLOSING. THERE WAS NO DIFFICULTY MOUNTING THE STENT. PROCESS FOR CRIMPING: SQUEEZED STENT. THE RING MANDRIL WAS NOT USED DURING THE CRIMPING PROCESS. THE STENT DID NOT SLIP. COVERING CAME OFF PRIOR TO INTRODUCTION INTO SHEATH. THE BLUE INTRODUCER TOOL WAS NOT USED. THE CATHETER SHAFT WAS NOT KINKED. ANOTHER COVERED CP STENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE PATIENT WAS FINE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12591612 ↗
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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