CP Stent™ 614308Recalls & reported problems
B Braun Interventional Systems, Inc · COVERED CP STENT 8Z 2.8CM · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964898792), received between Dec 15, 2016 and Jul 2, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Component Falling” (2 reports).
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
- Component Falling2
- Detachment Of Device Component1
- Device Dislodged or Dislocated1
- No Apparent Adverse Event1
Patient problems
- No Information2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2021No Apparent Adverse Event; No Apparent Adverse Event
AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR: PHYSICIAN WAS PREPPING AND THE STENT COVERING CAME OFF OF THE STENT, THE COVERING PEELED OFF. PHYSICIAN USED ANOTHER CP STENT THE EXACT SAME SIZE AND IT WORKED PERFECTLY. PHYSICIAN STATED THAT THIS HAS NEVER HAPPENED BEFORE. THE PRODUCT IS SAVED IN THE TUBE. THE SIZE OF THE BALLOON THE STENT WAS MOUNTED ON: BIB 16X3. PHYSICIAN BARELY BEGAN TO CRIMP AND THE COVERING CAME OFF OF THE STENT. THE RING MANDRIL WAS USED DURING THE CRIMPING PROCESS. THE COVERING CAME OFF BEFORE IT COULD BE USED. PHYSICIAN IS A LONG TIME CP STENT CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 12108329 ↗MalfunctionDec 15, 2016Detachment Of Device Component; Component Falling; Device Dislodged or Dislocated
AS PER THE REPORT FROM THE DISTRIBUTOR: "DURING DELIVERY, STENT WAS FOUND TO HAVE SHIFTED ON THE BIB. THEN THE PHYSICIAN TRIED TO RE-CRIMP THE STENT, THE COVER FELL OFF."
Patient problems: No Information
MAUDE report 6177128 ↗MalfunctionDec 15, 2016Component Falling
AS PER THE REPORT FROM THE DISTRIBUTOR: "COVER FELL OFF WHEN PASSING THE HEMSTATIC VALVE ON THE COOK SHEATH."
Patient problems: No Information
MAUDE report 6177055 ↗
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™ 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
- CP Stent™ 614509B Braun Interventional Systems, Inc · Aortic stent1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.