Cordis PRECISE PRO Rx Nitinol Stent System PC0630RXCRecalls & reported problems
Cordis US Corp. · Class 3 · Implant
All models of Cordis PRECISE PRO Rx Nitinol Stent System (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032036426), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
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
Device problems
- Crack1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2023Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
AS REPORTED, THE DISTAL PART OF THE PRECISE PRO RX CAROTID SELF-EXPANDING STENT WAS DISCOVERED BROKEN BY ABOUT 3MM DURING DELIVERY THROUGH THE FILTER WIRE AND ITS USE WAS DISCONTINUED. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17098110 ↗
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 · CompletedPRECISE 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, ClassifiedCordis 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 · TerminatedCordis PRECISE (R) RX Nitinol Stent System (Biliary)
- Z-1946-2016 · May 4, 2016 · TerminatedCordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
Other STENT, CAROTID devices
- Neuroguard IEP® System NG-0740-140-2Contego Medical, Inc. · Stent, Carotid2 recalls32 reports
- Neuroguard IEP® System NG-NV-6-40Contego Medical, Inc. · Stent, Carotid2 recalls9 reports
- Neuroguard IEP® System NG-NV-7-40Contego Medical, Inc. · Stent, Carotid2 recalls8 reports
- ENROUTE Transcarotid Stent SR-0940-CSSilk Road Medical, Inc. · Stent, Carotid1 recall5 deaths58 reports
- Neuroguard IEP® System NG-0640-140-2Contego Medical, Inc. · Stent, Carotid2 recalls7 reports
- ENROUTE Transcarotid Stent SR-1040-CSSilk Road Medical, Inc. · Stent, Carotid1 recall3 deaths56 reports
- CGuard Prime Carotid Stent System CND0840Inspire M.D Ltd · Stent, Carotid1 recall1 death41 reports
- CGuard Prime Carotid Stent System CND0940Inspire M.D Ltd · Stent, Carotid1 recall31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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