CP Stent™ 614309Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964898907), received between May 22, 2017 and Jan 3, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2020Unraveled Material

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - THE STENT COVER MATERIAL STARTED TO UNRAVEL FROM THE STENT AS IT WAS BEING ADVANCED THROUGH THE STENT INSERTION/DELIVERY TUBE. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR: PULMONARY ARTERY STENTING FOR PULMONARY VALVE IMPLANT. THE STENT WAS MOUNTED ON A 14MM X 4MM BIB 614412 WITHOUT DIFFICULTY. THE STENT WAS HAND CRIMPED, THE RING MANDRIL WAS USED DURING CRIMPING. THE STENT DID NOT SLIP. THE COVERING MATERIAL UNRAVELED DURING THE STENT ADVANCEMENT THROUGH THE INSERTION TOOL DURING INSERTION PAST THE SHEATH VALVE. THE BLUE INTRODUCER TOOL THAT CAM IN THE PACKAGE WAS USED. THERE WAS NO ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME. INCIDENT OCCURRED PRIOR TO THE NEED FOR INFLATION. A B. BRAUN 14FR D'VILL INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NO EVENT INVOLVING THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9548230 ↗
• MalfunctionAug 29, 2017Torn Material

  AS PER THE REPORT FROM BIS - "PHYSICIAN WAS CRIMPING THE STENT ON THE BALLOON. AFTER CRIMPING, PHYSICIAN NOTICED WHAT APPEARED TO BE SOME TEARS IN THE MATERIAL THAT WERE NOT BELIEVED TO BE CAUSED BY THE PHYSICIAN. THE STENT WAS REMOVED AND ANOTHER STENT PLACED. THE STENT WAS BEING MOUNTED ON A 10X3.5 BIB. THERE WAS NO DIFFICULTY MOUNTING THE STENT. CRIMPING WAS DONE BY HAND. THE RING MANDRIL WAS NOT USED DURING CRIMPING. THE STENT DID NOT SLIP. THE SLIGHT TEARS IN THE COVERING OF THE STENT WERE NOT BELIEVED TO BE CAUSED BY THE CRIMPING PROCESS. CONTRAST WAS BEING USED DURING PREP. PHYSICIAN WAS USING THE PRODUCT FOR SEVERE COARCTATION OF AORTA."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6826600 ↗
• MalfunctionMay 22, 2017Detachment Of Device Component; Device Slipped; Use of Device Problem; Failure to Advance

  AS REPORTED BY BRAUN: " CRIMPED ON TO BIB BALLOON, INSERTED TO SHEATH WITH THE HEMOSTASIS TOOL THE COVER CAME BACK AND ROLLED OFF. THIS HAPPENED TWO TIMES. WENT IN AND OUT OF THE HEMOSTASIS VALVE MULTIPLE TIMES PHYSICIAN RE-CRIMPED IT. ACCOUNT SAID IT COULD BE OPERATOR ERROR, PHYSICIAN'S FIRST TIME USING STENT UNAIDED. AS STENT WAS ADVANCING THROUGH, IT KEPT COMING OFF OF THE BALLOON. THERE WAS NO DIFFICULTY MOUNTING THE BALLOON. THE SIZE OF THE CATHETER THE STENT WAS MOUNTED ON: 16 MM X 4.5 CM BOTH, 2.2 STENT 3.4 STENT. BOTH SALINE AND CONTRAST MEDIA WERE USED DURING PREP. THE HEMOSTASIS TOOLS WERE USED THAT ARE PROVIDED BY NUMED - THSE SIZES: 16 & 18. THE STENT STARTED SLIPPING DURING INSERTION THROUGH THE SHEATH. THE INNER BALLOON WAS INFLATED BEFORE THE OUTER BALLOON ONCE THE 2 SUCCESSFUL STENTS WERE DEPLOYED. THEY ATTEMPTED TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE TO GET IT OUT. CRIMPING PROCESS USED: RING MANDRIL THROUGH END OF BALLOON WITH STENT ON IT, PUT IT IN BETWEEN MARKERS (2 OUTER IMAGE BANDS) COMPRESSED WITH THUMB AND INDEX ROLLED IT. USED UMBILICAL TAPE TO WRAP AROUND STENT AND FURTHER CRIMP DOWN. THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR - CO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6581064 ↗