Cordis PRECISE PRO Rx Nitinol Stent System PC0540RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032036402), received between Oct 29, 2018 and Feb 28, 2022 — classified as 2 injuries, 1 malfunction.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2022Premature Activation; Premature Activation

  AS PER SALES REP, THE 5X40MM PRECISE PRO RX SELF EXPANDING STENT (SES) WAS INSERTED INTO THE PATIENT AND PRIOR TO DEPLOYMENT IT WAS NOTICED THAT UNDER FLUORO THE TIP WAS FLARED. AN IMAGE OF THE DEVICE WAS PROVIDED INDICATES PREMATURE DEPLOYMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT. THERE WAS NO PATIENT INJURY. THE INTENDED PROCEDURE WAS A CAROTID STENTING. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO DIFFICULTY DURING PREPARATION OF THE DEVICE. THERE WAS DIFFICULTY INSERTING THE SES INTO THE SHEATH/INTO THE PATIENT BECAUSE IT HAD A FLARED TIP. THERE WAS NO EXCESSIVE FORCE USED. AN EMBOLIC PROTECTION DEVICE WAS USED IN THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618111 ↗
• InjuryJun 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING USE, THE SHAFT OF THE PRECISE SELF EXPANDING STENT (SES) CAME APART AS THEY WERE ATTEMPTING TO DELIVER IT TO THE CAROTID. THERE WAS NO PATIENT INJURY. DEVICE WAS STORED AS PER INSTRUCTION FOR USE (IFU).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678239 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD NECK PAIN AND SWELLING AFTER A 5X40 PRECISE PRO RX STENT WAS IMPLANTED RESULTING IN BLOCKAGE THE DAY AFTER IMPLANTATION. SHE HAD MENTIONED IT TO THE MEDICAL STAFF AND NO ACTION WAS TAKEN AT THE TIME. WHEN AN ULTRASOUND WAS PERFORMED, THE STENT WAS COMPLETELY CLOSED.

  Patient problems: Thrombosis

  MAUDE report 8014124 ↗

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)