Skip to content

CP Stent™ 614367Recalls & reported problems

B Braun Interventional Systems, Inc · CMCP018 Mounted Covered CP Stent 3.9 16 · Class 3 · Implant

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 04046964899478), received between Jun 23, 2023 and Jun 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1
  • Difficult to Insert1

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.

  • MalfunctionJun 23, 2023Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

    AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - MOUNTED COVERED CP WOULD NOT GO THROUGH A 12 FR D'VILL INTRODUCER. IT GOT STUCK IN THE SHEATH AND CAME OFF THE SHAFT. DR. KANTER CUT THE D'VILL TO TRY TO SALVAGE THE CP BUT IT WAS TOO DAMAGED TO BE USED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17192311 ↗

Other Aortic stent devices

All Aortic stent devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.