Cordis PRECISE PRO Rx Nitinol Stent System PC0840RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20705032036495), received between Oct 24, 2016 and Sep 25, 2023 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Fracture; Fracture

  AS REPORTED, AFTER DEPLOYING THE STENT OF AN 8MM X 40MM PRECISE PRO RX CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM IN THE RIGHT INTERNAL CAROTID ARTERY, AN ATTEMPT TO POST DILATE THE STENT WITH A NON-CORDIS 5.5MM X 20MM BALLOON CATHETER WAS MADE. HOWEVER, THE BALLOON CATHETER COULD NOT ADVANCE THROUGH THE IMPLANTED STENT AND A STENT FRACTURE WAS OBSERVED. THE FRACTURED STENT DID NOT APPEAR TO BE COMPLETELY SEPARATED. THE PROCEDURE ENDED AFTER UNSUCCESSFULLY CROSSING WITH THE NON-CORDIS BALLOON. THERE WERE NO REPORTED INJURIES TO THE PATIENT. A 7F RAIN CATHETER SHEATH INTRODUCER (CSI) WAS USED FOR ACCESS, AND A 7F NON-CORDIS GUIDING CATHETER WAS USED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807163 ↗
• InjuryFeb 16, 2022Migration; Migration

  DURING A CAROTID ARTERY STENTING (CAS) CASE, AN 8X40MM PRECISE PRO RXSELF EXPANDING STENT WAS IMPLANTED BUT AN UNKNOWN FILTER WIRE GOT STUCK ON THE STRUT OF THE STENT. IT WAS UNABLE TO COVER THE LESION THEREFORE, A NON-CORDIS STENT WAS IMPLANTED, ¿COVERING THE STRUT PART.¿ THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE SALES REP CANNOT VISIT THE HOSPITAL BECAUSE OF THE COVID-19. THEREFORE, ADDITIONAL INFORMATION CANNOT BE OBTAINED. THE DEVICE WILL NOT BE RETURNED BECAUSE IT WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541475 ↗
• InjuryJul 26, 2021Fracture; Fracture

  AS REPORTED, AN 8MM X 40MM PRECISE PRO CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS DEPLOYED IN THE PRESENCE OF A 95% STENOSIS AND WAS POST DILATED WITH A 5MM X 30MM NON-CORDIS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER; HOWEVER, IMAGES OF POST DILATION REVEALED STENT FRACTURE. THE FRACTURE WAS TREATED WITH A 7X15MM BALLOON EXPANDABLE CORONARY STENT PLACED ACROSS THE STRICTURED SEGMENT OF THE DEPLOYED RIGHT ICA STENT. THERE WAS GOOD COVERAGE OF THE FRACTURED AREA WITH IMPROVEMENT IN THE STENOSIS AT THE RIGHT ICA ORIGIN. A RIGHT CAROTID ARTERY STENTING PROCEDURE WAS BEING PERFORMED IN THE INTERNAL CAROTID ARTERY (ICA) AT A CAROTID BIFURCATION. THE 95% OCCLUDED LESION WAS 30MM IN LENGTH IN A 6.85MM IN DIAMETER THE COMMON CAROTID AND 3.78MM IN DIAMETER IN THE ICA. THE LESION WAS CALCIFIED BUT THERE WAS NO VESSEL TORTUOSITY. THE PRECISE STENT 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 6F NON-CORDIS SHEATH WAS USED IN THE PROCEDURE. THE DIAMETER OF THE UNCONSTRAINED STENT SIZE WAS 1-2 MM LARGER THAN THE VESSEL DIAMETER. THE STENT DELIVERY SYS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12224674 ↗
• MalfunctionJul 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN 8MM X 40MM PRECISE PRO CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS TRIED TO USE BECAUSE THERE WAS A LESION ON THE CAROTID SIDE; HOWEVER, THE STENT DID NOT PASS THROUGH THE BLOOD VESSEL. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR ANALYSIS AND A SEPARATION CONDITION WAS OBSERVED LOCATED AT 2 CM FROM THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148722 ↗
• MalfunctionApr 20, 2021Material Frayed; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Frayed; Detachment of Device or Device Component; Material Split, Cut or Torn

  AS REPORTED, THE CATHETER TIP OF THE PRECISE PRO RAPID EXCHANGE (RX) CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS NOTED TO HAVE FRAYED DISTAL END. THE DEVICE WAS NOT PLACED IN THE PATIENT¿S BODY. THE DEFECTIVE DEVICE WAS RECOGNIZED DURING DEVICE PREP AND THE DEVICE WAS REMOVED FROM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. THE DEVICE WAS STORED FOR APPROXIMATELY EIGHTEEN MONTHS. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NEVER PLACED ON THE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER PRECISE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693182 ↗
• MalfunctionAug 20, 2020Crack; Crack

  AS REPORTED, A CRACK WAS FOUND ON THE TIP OF AN 8MM X 40MM PRECISE PRO RAPID EXCHANGE (RX) CAROTID SELF EXPANDING STENT (SES) BEFORE USE, DURING PREP. ANOTHER PRECISE PRODUCT WAS THEREFORE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE TARGET LESION WAS CAROTID ARTERY (CA). THERE WAS NO VESSEL ANGULATION, CALCIFICATION OR TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS BETWEEN 50-60%, THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS INSPECTED BEFORE USE BUT DID NOT APPEAR TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB AND IF SO WHERE ANY ANOMALIES NOTED AT THIS TIME. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU) AND PREPPED NORMALLY (MAINTAINED NEGATIVE PRESSURE). THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10434311 ↗
• MalfunctionJun 19, 2020Difficult to Remove; Difficult to Remove

  DURING THE DELIVERY OF A PRECISE PRO RX US CAROTID STENT TO THE LESION, IT GOT STUCK AND COULD NOT BE REMOVED. HOWEVER, THE PHYSICIAN MANAGED TO REMOVE THE DEVICE FROM THE PATIENT'S BODY. THEREFORE, IT WAS REPLACED WITH A SAME SIZE UNKNOWN NEW DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A CAROTID ARTERY STENTING (CAS) CASE. AFTER PRE-DILATION WITH AN UNKNOWN BALLOON CATHETER, THE PRECISE PRO STENT WAS INSERTED. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173508 ↗
• MalfunctionMay 26, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A SIGNIFICANT KINKED OF THE DELIVERY SHAFT NEAR THE STENT WAS FOUND WHEN THE PACKAGE OF 8X40 PRECISE PRO RAPID EXCHANGE (RX) WAS OPENED. ADDITIONAL INFORMATION WAS RECEIVED FROM FAL AND THE STENT WAS OBSERVED DEPLOYED APPROXIMATELY 8 MM FROM THE UNIT. THE DEVICE COULD NOT BE USED; THEREFORE, IT WAS REPLACED WITH A NEW STENT TO COMPLETE THE OPERATION. THERE WAS NO REPORTED PATIENT INJURY. MEDICAL HISTORY INCLUDED LEFT CAROTID ARTERY STENOSIS. THE DEVICE WAS STORED, PREPPED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WERE NO ANOMALIES NOTED TO THE PACKAGING OF THE DEVICE. THE LESION WAS CALCIFIED. THERE WAS SEVERE VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS AT 70%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086630 ↗
• MalfunctionApr 9, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE TWO (2) 8MM X 40MM PRECISE PRO RX SELF-EXPANDING STENT (SES) DELIVERY SYSTEM DID NOT WORKED IN THE CAROTID ARTERY. ADDITIONAL INFORMATION WAS RECEIVED AND PER VISUAL ANALYSIS OF ONE OF THE PRECISE PRO STENT RECEIVED; THE STENT OF THE UNIT WAS RECEIVED 2.0 CM PRE-DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943294 ↗
• InjuryMar 23, 2020Activation Failure; Activation Failure

  AS REPORTED, PATIENT INTENDED PROCEDURE WAS TO STENT THE INTERNAL CAROTID ARTERY. THE PATIENT PRESENTED INITIALLY WITH A 99% OCCLUSION OF THE ARTERY. THE OCCLUSION WAS PASSED WITH AN 0.014 WIRE AND NO EMBOLISM PROTECTION DEVICE WAS USED. A 4X20 PRE DILATATION BALLOON WAS INSERTED AND INFLATED, AFTER REMOVAL THE 8MM X 40MM PRECISE PRO RX CAROTID STENT WAS INSERTED AND DEPLOYED. A 7X40 POST DILATION BALLOON WAS INSERTED AND INFLATED. THE BALLOON AND WIRE WERE REMOVED, AND A FINAL SHOT WAS TAKEN WITH AN OPEN AND PATENT VESSEL. HOWEVER, DURING CLOSING PROCEDURES WAS WHEN THE PATIENT PRESENTED WITH STROKE AND SEIZURE LIKE SYMPTOMS, THE PATIENT AT THIS TIME WAS INTUBATED AND PHYSICIAN SENT THE PATIENT TO COMPUTERIZED TOMOGRAPHY (CT) FOR A STAT CT ANGIO. THE CT READ BY A SECOND PHYSICIAN SHOWED INDICATIONS OF A CLOSED OR COLLAPSED CAROTID ARTERY. THE PATIENT WAS PLACED BACK ONTO THE INTERVENTIONAL RADIOLOGY (IR) ROOM TABLE AND INTERVENTION WAS RESTARTED. A WIRE WAS RE-PASSED ACROSS THE LESION AND STENT. MULTIPLE BALLOON ATTEMPTS HAPPENED WITHOUT SUCCESS. THE DECISION WAS MADE TO PLACE ANOTHER 8MM X 30MM PRECISE STENT INSIDE OF THE EXISTING STENT. AFTER PLACEMENT THE VESSEL WAS AGAIN OPEN.

  Patient problems: Seizures; Stroke/CVA

  MAUDE report 9868382 ↗
• MalfunctionAug 5, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A PRECISE PRO (RX US CAROTID SYST) SELF-EXPANDING STENT (SES) WAS DEPLOYED PARTIALLY BEFORE PUTTING IT INTO THE BODY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING. THE DEVICE WAS OPENED IN STERILE FIELD. THE PRECISE SES STENT WAS NOT USED IN PATIENT. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOT BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THE STENT PARTIALLY DEPLOYED WHEN REMOVING. THE PRECISE STENT PRE-MATURELY DEPLOYED. THE STENT DEPLOYED ¼ OF IT. THERE WAS NO ATTEMPT MADE TO RE-CAPTURE THE STENT. THE STENT WAS NEVER IMPLANTED. THERE ARE NO PICTURES AVAILABLE OF THE CORDIS DEVICES USED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861886 ↗
• MalfunctionOct 24, 2016Failure To Adhere Or Bond; Failure To Adhere Or Bond

  AS REPORTED, THE PRECISE PRO RX STENT BUNCHED AT THE DISTAL END. DEPLOYMENT RESISTANCE WAS AVERAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6050528 ↗

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)