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CP Stent™ 614310Recalls & reported problems

B Braun Interventional Systems, Inc · COVERED CP STENT 8Z 3.9CM · Class 3 · Implant

All models of CP Stent (16)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 04046964898914), received between Dec 15, 2016 and Sep 4, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 Component2
  • Detachment Of Device Component1
  • Malposition of Device1

Patient problems

  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 4, 2019Detachment of Device or Device Component

    AS PER THE REPORT FROM THE HOSPITAL / DISTRIBUTOR - THE SLEEVE DETACHED AND BEGAN TO SLIP OFF THE STENT WHEN CRIMPING ONTO THE BIB. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR: COARCTATION OF THE AORTA. THE BALLOON THE STENT WAS BEING MOUNTED ON: BB033. THEY DID NOT COMPLETELY MOUNT THE STENT DUE TO THE SLEEVE SEPARATING FROM THE STENT. THEY PLACED ANOTHER CP STENT WITH SUCCESS. THE STANDARD PROCESS OF CRIMPING WAS USED. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS NOT USED. THEY DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME. SALINE WAS USED DURING PREP. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE CATHETER SHAFT WAS NOT KINKED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8961013 ↗
  • MalfunctionAug 31, 2018Detachment of Device or Device Component

    AS REPORTED BY BIS "TEFLON COVER DETACHED FROM THE STENT. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR: COARCTATION REPAIR. THE BALLOON THE STENT WAS MOUNTED ON: 12X4 BIB. THE CRIMPING PROCESS USED: CRIMPED USING UMBILICAL TAPE AND LIGHT FINGER PRESSURE. THE RING MANDRIL WAS USED DURING THE CRIMPING PROCESS. THE STENT DID NOT SLIP. THE COVERING BECAME DETACHED AS THE BIB/STENT WAS BEING ADVANCED INTO THE SHEATH USING THE LOADER PROVIDED WITH THE STENT. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE INSERTING THE BIB/STENT INTO THE INTRODUCER. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS USED. ACCOUNT DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE. SALINE MEDIA WAS USED DURING PREP. THE BALLOON WAS NOT INFLATED. A 9F INTRODUCER SHEATH WAS USED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE CATHETER SHAFT WAS NOT KINKED. THE PATIENT CONDITION POST PROCEDURE WAS NORMAL". "THE 12F HEMOSTASIS TOOL WAS USED".

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7838037 ↗
  • MalfunctionDec 15, 2016Detachment Of Device Component; Malposition of Device

    AS PER THE REPORT FROM THE DISTRIBUTOR: "DURING DELIVERY, THE STENT WAS NOTICED TO BE SHIFTED FROM THE BALLOON. WHEN THE PHYSICIAN TRIED TO WITHDRAW THE SYSTEM TO REPOSITION THE STENT, THE COVER FELL OFF."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6177165 ↗

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Sources and updates

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