Cordis PRECISE PRO Rx Nitinol Stent System PC0740RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032036464), received between Dec 1, 2017 and Nov 16, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (P030047); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A PRECISE PRO RX CAROTID SELF-EXPANDING STENT COULD NOT BE USED TO DO A CAROTID ARTERY STENTING (CAS) BECAUSE IT COULD NOT CROSS THE BLOOD VESSEL AND WAS BENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND WAS PARTIALLY DEPLOYED. IT WAS FURTHER CONFIRMED THAT THE PARTIALLY DEPLOYED CONDITION OCCURRED DURING USE IN THE PATIENT. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155050 ↗
• MalfunctionAug 6, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED, A BOX OF THE PRECISE PRO RAPID EXCHANGE (RX) CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS OPENED BUT THE DEVICE WAS ALREADY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE DEVICE WAS STORED IN A WAREHOUSE IN A CATH ROOM WHERE HUMIDITY AND TEMPERATURE ARE CONTROLLED. THERE WAS NO DAMAGE TO ANY OF THE PACKAGING. ADDITIONAL PATIENT AND PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT AVAILABLE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287661 ↗
• MalfunctionJul 22, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE PRECISE PRO RX US CAROTID SYST STENT WAS PARTIALLY DEPLOYED WITHIN THE STERILE PACKAGING. THERE WERE NO REPORTED PATIENT INJURIES. THE PRODUCT WAS STORED, HANDLED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO VISIBLE DAMAGE TO THE PACKAGE OR THE ITEM. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813654 ↗
• MalfunctionJul 17, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE PRECISE PRO RX (US CAROTID SYST) STENT WAS PARTIALLY DEPLOYED WITHIN THE STERILE PACKAGE. THE PRODUCT WAS STORED AND HANDLED IN ACCORDANCE WITH THE IFU. THERE WAS NO VISIBLE DAMAGE TO THE PACKAGE OR THE ITEM. THERE WAS NO FURTHER INFORMATION AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 8799931 ↗
• MalfunctionDec 1, 2017Crack; Crack

  IT WAS REPORTED THAT THE TIP OF THE PRECISE STENT WAS DEFORMED; ADDITIONAL INFORMATION WAS RECEIVED AND THE TIP OF THE PRECISE STENT IS CRACKED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. A PRECISE PRO WAS PREPARED AND USED. HOWEVER, THE DISTAL TIP WAS DEFORMED AND AN UNKNOWN GUIDEWIRE COULD NOT BE INSERTED. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WAS NO EXCESS FORCE USED DURING PREP. THERE WERE NO DAMAGES NOTED TO THE DEVICE PACKAGING. THERE WERE NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS STORED ACCORDING TO THE IFU. THE PRODUCT WAS CLINICALLY USED, DISCARDED, AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7076754 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030047. One submission often covers many models, so check the product and lot details in each record.

• Z-1257-2021 · Feb 11, 2021 · Completed
  PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC
• Z-0729-2020 · Nov 14, 2019 · Open, Classified
  Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vascula
• Z-1946-2016 · May 4, 2016 · Terminated
  Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
• Z-1947-2016 · May 4, 2016 · Terminated
  Cordis PRECISE (R) RX Nitinol Stent System (Biliary)