Cordis PRECISE PRO Rx Nitinol Stent System PC1030RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032036549), received between Nov 21, 2017 and Jul 29, 2022 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A 10MM X 30MM PRECISE PRO RX CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS BEING USED TO TREAT A CAROTID LESION BUT DID NOT DEPLOY NORMALLY. AS A RESULT, THE PATIENT WAS SENT TO SURGERY. THE DELIVERY SYSTEM WILL BE RETURNED WITHOUT THE STENT ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128484 ↗
• MalfunctionJan 14, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, PRECISE PRO RX WAS ATTEMPTED TO BE REMOVED AFTER IMPLANTATION, HOWEVER THERE WAS RESISTANCE FELT. WHEN THE PRECISE PRO WAS REMOVED IT WAS OBSERVED THAT THE SHAFT OF THE COMPLAINT PRECISE PRO WAS SEPARATED. THERE WERE NO REPORTED PATIENT INJURIES. THIS WAS A CAROTID ARTERY STENTING (CAS) CASE. A PRE DILATION WAS PERFORMED WITH A NON- CORDIS SHEATH, A NON-CORDIS FILTER WIRE (3.5-5.0MM) AND AN AVIATOR (4.5*30MM). A POST DILATION WAS ATTEMPTED TO BE PERFORMED WITH AN AVIATOR (5.0*30MM) BUT IT COULD NOT BECAUSE THERE WAS STRONG RESISTANCE FELT BETWEEN THE FILTER WIRE. SO, THE FILTER WIRE WAS REMOVED WITH A NON-CORDIS CATHETER BECAUSE A NON-CORDIS GUIDE EXTENSION CATHETER COULD NOT BE INSERTED. IT WAS CONFIRMED THAT THE DISTAL END OF THE COMPLAINT PRECISE PRO WAS REMOVED WITH THE FILTER WIRE. THE PHYSICIAN CONFIRMED THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED AFTER HEMOSTASIS WAS ACHIEVED BY USING A NON-CORDIS HEMOSTASIS DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8244084 ↗
• InjuryApr 23, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A PRECISE PRO RX US 10 X 30 STENT DELIVERY SYSTEM (SDS) WAS DELIVERED TO THE TARGET LESION. DURING DEPLOYMENT, THERE WAS SOME RESISTANCE FELT AND THE STENT JUMPED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PRECISE STENT WAS IMPLANTED DISTAL TO THE INTENDED TARGET LESION. ADDITIONAL INTERVENTION/AN ADDITIONAL STENT WAS IMPLANTED TO TREAT THE INTENDED TARGET LESION. THE TARGET LESION WAS THE LEFT INTERNAL CAROTID ARTERY (LICA). THE TARGET LESION WAS REPORTED TO BE: SLIGHTLY TORTUOUS, SEVERELY CALCIFIED, AND A SEVENTY-FIVE PERCENT (75%) STENOSIS. THE PRODUCT IS NOT BEING RETURNED FOR INSPECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451636 ↗
• InjuryNov 21, 2017Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PRECISE PRO RX STENT WOULD NOT LOAD ON THE WIRE AS THERE SEEMED TO BE SOMETHING INHIBITING THE DISTAL WIRE PORT OF THE STENT. THE DEVICE WAS DISCARDED AND NEVER ENTERED THE PATIENT IN A RUSH BECAUSE THE ANGIOGUARD FILTER WAS READY FOR USE. A NEW PRECISE STENT WAS LOADED ON THE WIRE WITH NO DIFFICULTY. AFTER THE PRECISE STENT WAS IMPLANTED, THE FILTER WAS EXTRACTED FROM THE PATIENT AND IT WAS NOTICED THAT THE FILTER BASKET SEEMED TORN ALONE ONE SIDE. THIS MOST LIKELY HAPPENED DURING THE RETRIEVAL OF THE FILTER. THE PHYSICIAN SAID THAT THE ANGIOGUARD FILTER DID NOT FEEL CAUGHT ON THE STENT. HOWEVER, THE PHYSICIAN EXAMINED UNDER XRAY DURING RETRIEVAL AND THE FILTER STOPPED WITHIN THE STENT. THEN ALL OF THE SUDDEN JERKED OUT QUICKLY. THE PHYSICIAN WAS UNABLE TO TELL IF THE FILTER WAS CAUGHT, THEN CAME FREE OR IF HE JUST YANKED IT OUT QUICKLY. THE PATIENT EXPERIENCE SLURRED SPEECH AND LEFT FACIAL DROOP DURING THE MIDDLE OF THE PROCEDURE. A NEUROLOGIST SPECIALIST WAS CALLED IN, A CLOT WAS LOCATED IN A SMALL BRANCH OF THE BRAIN. THE NEUROLOGIST SPECIALIST CONCLUDED THAT THE VESSEL WAS TOO SMALL TO RETRIEVE THE EMBOLI. THE NEUROLOGIST LATER FOLLOWED UP WITH THE PHY

  Patient problems: Stroke/CVA

  MAUDE report 7048754 ↗

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)