Cordis PRECISE PRO Rx Nitinol Stent System PC0830RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032036488), received between Mar 31, 2017 and Jul 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, AN 8MM X 30MM PRECISE PRO RX SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS UNABLE TO CROSS THE TARGET VESSEL AND THE CATHETER BECAME STUCK. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A CAROTID LESION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315229 ↗
• MalfunctionOct 17, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AN 8X30 PRECISE RX SELF EXPANDING STENT DID NOT. CROSS THE LESION. THERE WAS NO PATIENT INJURY. ANALYSIS OF THE RETURNED DEVICE INDICATED THE STENT WAS PARTIALLY DEPLOYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973237 ↗
• MalfunctionMar 31, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, WHILE REMOVING THE PRECISE PRO RX US CAROTID SYSTEM FROM THE PACKAGING IT WAS FOUND THAT THE SYSTEM WAS PARTIALLY DEPLOYED. ANOTHER PRECISE PRO STENT WAS USE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT INJURY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  THERE WERE NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE DEVICE WAS STORED IN THE LAB FOR 3 MONTHS. THERE WERE NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGE. THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6449243 ↗

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-1947-2016 · May 4, 2016 · Terminated
  Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
• Z-1946-2016 · May 4, 2016 · Terminated
  Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)