Cordis PRECISE PRO Rx Nitinol Stent System PC0520RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032036389), received between Aug 6, 2019 and Aug 21, 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.

• MalfunctionAug 21, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, AFTER FLUSHING A 5MM X 20MM PRECISE PRO RX CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, THE STENT WAS DEPLOYED PRIOR TO ENTERING AN UNKNOWN GUIDING SHEATH. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT DIFFICULTY. THE PRECISE PRO DELIVERY SYSTEM WAS BEING ADVANCED ALONG AN UNKNOWN GUIDEWIRE WHEN THE STENT DEPLOYED; HOWEVER, THERE WAS NO RESISTANCE/FRICTION BETWEEN THE DELIVERY SYSTEM AND THE GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584559 ↗
• MalfunctionSep 9, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, IT WAS FOUND THAT A PRECISE PRO RX SELF-EXPANDING STENT (SES) GOT DEPLOYED LITTLE BEFORE USAGE. THE DEVICE WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS CAROTID ARTERY STENTING (CAS). THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU AND IT WAS PREPPED IN THE TRAY. THE TUOHY BORST VALVE WAS CLOSED PRIOR TO REMOVING THE DEVICE FROM THE TRAY. THE PROCEDURE WAS COMPLETED WITH A NEW PRECISE PRO RX SES. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8975183 ↗
• MalfunctionAug 6, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED, CUSTOMER MENTIONED THAT INFORMATION PRESENTED IN WEBSITE IS OUTDATED AND DOES NOT ALIGN WITH A LETTER/OTHER MORE UPDATED MRI INFORMATION IN A DIFFERENT IFU. THERE WAS NO REPORTED PATIENT INJURY. INITIALLY, THE CUSTOMER CALLED THE SERVICE NUMBER ON THE DOCUMENT PREVIOUSLY SENT BY SALES REP AND ALSO EMAILED THE INSTRUCTIONS FOR USE. UNFORTUNATELY, THEY STATE 1.5 TESLA, WITH A SPATIAL GRADIENT LIMIT OF 3 T/M (300 G/CM). THE SPATIAL GRADIENT IS NOT THE SAME AS FIELD STRENGTH. ALTHOUGH THE DOCUMENT STATES SOME STENTS WERE TESTED ON A 3 TESLA MAGNET, IS DOES NOT STATE THE SPATIAL GRADIENT OF THOSE SYSTEMS AND/OR ANY OTHER CONDITIONS FOR USE. PER CUSTOMER ¿THEY CAN REALLY ONLY SAFELY SCAN DEVICES AND IMPLANTS WHILE FOLLOWING THE SPECIFIC FDA APPROVED GUIDELINES PUBLISHED IN THE INSTRUCTIONS FOR USE FOR MANUFACTURER GUIDELINES FOR IMPLANTS RATED CONDITIONAL 5. THE CORDIS PRECISE STENTS ARE RATED CONDITIONAL 5, BUT FROM WHAT I CAN TELL THE INSTRUCTIONS FOR USE STATE 1.5 TESLA ONLY, WITH A VERY LOW SPATIAL GRADIENT LIMIT¿. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864166 ↗

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)