CP Stent™ 614311Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964898921), received between Dec 15, 2016 and May 6, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Falling” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2022Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event

  AS PER THE REPORT SENT IN FROM THE DISTRIBUTOR / USER FACILITY - WHILE PREPPING THE STENT, THE GORTEX COVER CAME OFF OF THE METAL STENT FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14305162 ↗
• MalfunctionNov 12, 2020No Apparent Adverse Event; Device Handling Problem; No Apparent Adverse Event; Device Handling Problem

  AS REPORTED TO NUMED BY THE DISTRIBUTOR / USER FACILITY - WHILE CRIMPING THE STENT ONTO A 24X4 BIB THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE COVERING WAS SLIDING OFF THE STENT. THE INDICATION THE PHYSICIAN AS USING THE PRODUCT FOR: INTIMAL TEAR IN RV-PA CONDUIT. THERE WAS NO DIFFICULTY MOUNTING THE STENT. CRIMPING WAS MANUAL, BY HAND. THE RING MANDRIL WAS NOT USED DURING THE CRIMPING PROCESS. THE STENT WAS NOT USED ON THE PATIENT. 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. CONTRAST MEDIA WAS USED DURING PREP. THE BALLOON WAS NOT INFLATED, NO INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10828360 ↗
• MalfunctionFeb 24, 2020Detachment of Device or Device Component

  AS REPORTED BY THE DISTRIBUTOR / USER FACILITY - THE SLEEVE JUST CAME OFF THE STENT. I INTRODUCED THE CP COVERED STENT THE WAY I ALWAYS INTRODUCE IT, BUT IT WAS SOMEWHAT DIFFICULT TO GET THROUGH THE 14FR D'VILL SHEATH. THE STENT WAS ON AN 18MM BIB AND IT SHOULD HAVE GONE WITHOUT A SNAG. WE REDID IT WITH A DIFFERENT CP STENT AND EVERYTHING WENT GREAT AND NO SNAGS, SO I DON'T KNOW IF THERE WAS SOMETHING WITH THE SLEEVE ITSELF BUT THE SLEEVE COMPLETELY CAME OFF. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR WAS COARCTATION OF THE AORTA. THERE WAS NO DIFFICULTY MOUNTING THE STENT. THE COVERING CAME COMPLETELY OFF WHEN BEING INTRODUCED INTO THE 14FR D'VILL. (B)(6) 2020 - IN AN EMAIL FROM THE ACCOUNT: ONLY SALINE WAS USED DURING THE PREP. PHYSICIAN HAND MOUNTED IN THE USUAL WAY AND USED THE ENCLOSED SLEEVE TO INTRODUCE THROUGH THE VALVE OF THE D'VILL SHEATH. INSTRUCTIONS FOR USE AND MOUNTING PROCEDURE WERE FOLLOWED. THE 14FR INTRODUCER INCLUDED IN THE PACKET WITH THE CP COVERED STENT WAS USED. WITH INTRODUCTION OF THE STENT/BALLOON COMPLEX PHYSICIAN FELT RESISTANCE GOING THROUGH THE D'VILL SHEATH. PHYSICIAN DID NOT FEEL COMFORTABLE PUSHING ANY FURTHER AND THEREFORE REMOVED THE C

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9744204 ↗
• MalfunctionMar 1, 2018Torn Material

  AS PER THE REPORT FROM (B)(4): "THE COVERING OF THE CP STENT WAS TORN AND UNUSABLE UPON REMOVAL FROM PACKAGING. THE STENT WAS NOT USED. THE PHYSICIAN WAS GOING TO USE THE PRODUCT FOR STENT PLACEMENT IN RVOT PRIOR TO TPVR. NO CRIMPING WAS INVOLVED. THE CATHETER SHAFT WAS NOT KINKED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7305764 ↗
• MalfunctionFeb 8, 2017Detachment Of Device Component

  AS PER THE REPORT FROM (B)(6): "PHYSICIAN WENT INTO THE BODY WITH THE UNMOUNTED STENT ON A BIB BALLOON, AND REMOVED THE STENT FROM THE BODY TO REPOSITION. IT WAS THEN NOTICED THAT THE COVERING WAS STARTING TO COME OFF THE STENT. PHYSICIAN DECIDED NOT TO RE-ENTER THE BODY WITH THIS STENT, THEN OPENED A PRE MOUNTED CP STENT IN THE SAME SIZE WHICH WAS DEPLOYED WITHOUT INCIDENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6311655 ↗
• MalfunctionDec 15, 2016Component Falling

  PER THE REPORT FROM THE DISTRIBUTOR: "COVER FELL OFF WHEN REMOVING THE PROTECTOR SHEATH. USED 12F PROTECTOR SHEATH, 12F COOK SHEATH, 14 X 4.5 BIB. MOUNTED DRY.

  Patient problems: No Information

  MAUDE report 6177001 ↗