Cordis PRECISE PRO Rx Nitinol Stent System PC0930RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032036518), received between Nov 20, 2020 and Sep 19, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionSep 19, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ACCORDING TO THE PRODUCT EVALUATION, THE STENT WAS PARTIALLY DEPLOYED WHEN RECEIVED. PER THE SALES REPRESENTATIVE, IT IS DIFFICULT TO CONFIRM WHEN THE STENT DEPLOYMENT OCCURRED; IF THE STENT DEPLOYED DURING THE PROCEDURE OR IF THIS OCCURRED DURING SHIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772473 ↗
• MalfunctionFeb 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 9MM X 30MM PRECISE PRO RAPID EXCHANGE (RX) CAROTID STENT SYSTEM WAS IMPLANTED. AFTER THAT, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE DEVICE WAS SEPARATED. IT WAS DIFFICULT TO REMOVE THE SEPARATED PART, BUT IT WAS REMOVED TOGETHER WHEN THE PHYSICIAN REMOVED A NON-CORDIS FILTER WIRE. THERE WAS NO PATIENT INJURY REPORTED AND THE PROCEDURE WAS COMPLETED. THIS WAS A CAROTID ARTERY STENTING (CAS) CASE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. NO DAMAGES WERE NOTED TO THE DEVICE PRIOR TO USING. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE PRECISE PRO WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU). THE TARGET SITE WAS THE RIGHT INTERNAL CAROTID ARTERY WHICH WAS 75 PERCENT STENOSED. THE ACCESS SITE WAS THE LEFT FEMORAL ARTERY. IT WAS VERIFIED PRIOR TO INSERTION THAT STENT WAS CONTAINED WITHIN THE OUTER SHEATH/INTRODUCER OF THE SYSTEM. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WILL BE RETURNED FOR EVALUATION TOGETHER WITH NON-CORDIS FILTER WIRE.

  Patient problems: Insufficient Information

  MAUDE report 11260051 ↗
• MalfunctionNov 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AFTER A 6MM X 30MM PRECISE PRO RAPID EXCHANGE STENT WAS IMPLANTED IN THE COMMON CAROTID ARTERY OVERLAPPING ANOTHER STENT, THE DISTAL TIP WAS NOT THERE WHEN THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PATIENT. THE PHYSICIAN WAS CONVINCED THAT IT MUST BE ON THE NON-CORDIS WIRE, SO POST-DILATION OF THE STENT WAS DONE. THE DISTAL TIP OF THE SDS WHICH WAS RELEASED FROM THE PRECISE STENT WAS ON THE TIP OF THE BALLOON USED FOR POST-DILATATION. THE WIRE WITH THE CATHETER TIP WAS EASILY REMOVED FROM THE PATIENT BY PULLING IT OUT THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED AND THE PROCEDURE WAS COMPLETED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE INTENDED PROCEDURE WAS CAROTID ARTERY STENTING. THE 75% OCCLUDED LESION WAS ABOUT 4CM IN LENGTH IN A -6MM~9MM VESSEL DIAMETER. THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY. 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, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. A 9F SHEATH INTRODUCER AND A 9F GUIDING CATH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875264 ↗

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)