Cordis PRECISE PRO Rx Nitinol Stent SystemRecalls & reported problems across all models

We found 10 models of Cordis PRECISE PRO Rx Nitinol Stent System by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2016 and Nov 30, 2023 — classified as 17 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Cordis PRECISE PRO Rx Nitinol Stent System problems

Cordis PRECISE PRO Rx Nitinol Stent System models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cordis PRECISE PRO Rx Nitinol Stent System PC1040RXC

  STENT, CAROTID
  16 reports
• Cordis PRECISE PRO Rx Nitinol Stent System PC0840RXC

  STENT, CAROTID
  12 reports
• Cordis PRECISE PRO Rx Nitinol Stent System PC0940RXC

  STENT, CAROTID
  9 reports
• Cordis PRECISE PRO Rx Nitinol Stent System PC0740RXC

  STENT, CAROTID
  5 reports
• Cordis PRECISE PRO Rx Nitinol Stent System PC1030RXC

  STENT, CAROTID
  4 reports
• Cordis PRECISE PRO Rx Nitinol Stent System PC0520RXC

  STENT, CAROTID
  3 reports
• Cordis PRECISE PRO Rx Nitinol Stent System PC0540RXC

  STENT, CAROTID
  3 reports
• Cordis PRECISE PRO Rx Nitinol Stent System PC0930RXC

  STENT, CAROTID
  3 reports
• Cordis PRECISE PRO Rx Nitinol Stent System PC0730RXC

  STENT, CAROTID
  2 reports
• Cordis PRECISE PRO Rx Nitinol Stent System PC0630RXC

  STENT, CAROTID
  1 report

Recent Cordis PRECISE PRO Rx Nitinol Stent System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE OUTER OF THE 9X40 PRECISE PRO RX WAS BEING RETRACTED FOR STENT DEPLOYMENT. HOWEVER, IT WAS TOO STIFF TO BE DEPLOYED. THE PRECISE PRO RX WAS REPLACED WITH ANOTHER PRECISE PRO RX AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE STENT DEPLOYMENT WAS ATTEMPTED OUTSIDE THE PATIENT, THE PHYSICIAN FELT RESISTANCE THAT WAS NOT THE HARDNESS TO PUSH OUT THE STENT BEFORE IT WAS DEPLOYED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236386 ↗
• MalfunctionNov 16, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A PRECISE PRO RX CAROTID SELF-EXPANDING STENT COULD NOT BE USED TO DO A CAROTID ARTERY STENTING (CAS) BECAUSE IT COULD NOT CROSS THE BLOOD VESSEL AND WAS BENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND WAS PARTIALLY DEPLOYED. IT WAS FURTHER CONFIRMED THAT THE PARTIALLY DEPLOYED CONDITION OCCURRED DURING USE IN THE PATIENT. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155050 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 21, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, AFTER FLUSHING A 5MM X 20MM PRECISE PRO RX CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, THE STENT WAS DEPLOYED PRIOR TO ENTERING AN UNKNOWN GUIDING SHEATH. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT DIFFICULTY. THE PRECISE PRO DELIVERY SYSTEM WAS BEING ADVANCED ALONG AN UNKNOWN GUIDEWIRE WHEN THE STENT DEPLOYED; HOWEVER, THERE WAS NO RESISTANCE/FRICTION BETWEEN THE DELIVERY SYSTEM AND THE GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584559 ↗
• MalfunctionJun 23, 2023Material Frayed; Difficult to Remove; Material Split, Cut or Torn; Material Frayed; Difficult to Remove; Material Split, Cut or Torn

  AS REPORTED, AFTER DEPLOYING THE STENT OF A 9MM X 40MM PRECISE PRO RX SELF-EXPANDING (SES) DELIVERY SYSTEM, THE DISTAL TIP OF THE DELIVERY SYSTEM AND A NON-CORDIS FILTER WIRE INTERFERED WITH EACH OTHER. THE DELIVERY SYSTEM BECAME STUCK AT THE COMMON CAROTID (CC) BIFURCATION INTO THE INTERNAL CAROTID (IC) AND WAS UNABLE TO BE RETRACTED. AS A RESULT, THE SHAFT OF THE DELIVERY SYSTEM AND THE NON-CORDIS FILTER WIRE WERE RETRACTED TOGETHER WITH FORCE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE STENT REMAINED IMPLANTED AT ITS TARGET LOCATION DURING THE REMOVAL OF THE DELIVERY SYSTEM AND NOTHING ELSE WAS LEFT IN THE PATIENT¿S BODY. THIS WAS DURING A PROCEDURE TO TREAT AN 80% STENOSED LEFT INTERNAL CAROTID ARTERY LESION WHICH HAD SEVERE TORTUOSITY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DAMAGES TO THE DEVICE OR THE DEVICE PACKAGING PRIOR TO USE. AN IPSILATERAL APPROACH WAS USED FOR THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: THE PRODUCT EVALUATION REVEALED THAT THE DISTAL TIP OF THE GUIDEWIRE LUMEN WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189949 ↗
• 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 ↗
• MalfunctionMar 6, 2023Material Frayed; Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Frayed; Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn

  AS REPORTED, THE PRECISE PRO WAS DEPLOYED WITH THE USE OF A NON-CORDIS PROTECTION DEVICE. AFTER STENT DEPLOYMENT THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM BUT THERE WAS AN INTENSIVE RESISTANCE FELT AT THE EXIT PORT OF THE NON-CORDIS PROTECTION DEVICE. THE PHYSICIAN PUSHED THE BRIGHT TIP OF THE OUTER MEMBER TO THE TIP OF THE INNER SHAFT, AND TRIED TO REMOVE IT, BUT FELT RESISTANCE. THE PHYSICIAN WAS ABLE TO PULL IT OUT AFTER DOING IT SEVERAL TIMES. IT WAS THAN NOTICED THAT IT LOOKED LIKE THERE WAS A HANGNAIL ON THE TIP OF THE INNER SHAFT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16489366 ↗
• MalfunctionSep 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, THE STENT OF A PRECISE PRO RX CAROTID STENT SYSTEM COULD NOT BE DEPLOYED DURING A CAROTID ARTERY STENTING (CAS) PROCEDURE. THE OPERATOR FLUSHED THE STENT SUFFICIENTLY AND DEPLOYED IT SEVERAL TIMES. THE STENT IS ONLY "TENSIONED" AND COULD NOT BE DEPLOYED AT ALL; THEREFORE, THE OPERATOR REMOVED THE DEVICE. THE STENT WAS ATTEMPTED TO BE DEPLOYED SEVERAL TIMES. DEPLOYMENT DID NOT WORK SO THE DEVICE WAS REMOVED FROM THE PATIENT AND THEN TRIED FROM THE OUTSIDE. THERE WERE NO ISSUES WHEN THE OPERATOR USED ANOTHER UNKNOWN SAME SIZED DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY. THE PRECISE PRO DEVICE WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). AFTER THE PROCEDURE, THE OPERATOR FORCED THE DEVICE OUTSIDE AND DEPLOYED IT AND THE STENT WAS DEPLOYED ONLY UNTIL IT OPENED. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE STENT WAS ATTEMPTED TO BE DEPLOYED SEVERAL TIMES. DEPLOYMENT DID NOT WORK SO THE DEVICE WAS REMOVED FROM THE PATIENT AND THEN TRIED FROM THE OUTSIDE. THE STENT COULD NOT BE DEPLOYED AT ALL. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15478115 ↗
• InjurySep 12, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, WHILE ATTEMPTING TO DEPLOY A 10MM X 40MM PRECISE PRO RX CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, THE INNER CYLINDER WAS FIXED, AND THE OUTER MEMBER WAS RETRACTED. HOWEVER, THE STENT WAS UNABLE TO DE DEPLOYED. EXCESS FORCE WAS USED TO FURTHER RETRACT THE OUTER MEMBER AND ONLY THE DISTAL TIP OF THE STENT WAS ABLE TO BE DEPLOYED. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407117 ↗
• 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 ↗
• MalfunctionJun 6, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE PRECISE PRO RX COULD NOT BE DEPLOYED AFTER PRE-DILATION AND BEING DELIVERED TO THE LESION. IT WAS NOTED THAT IT WAS HARD TO PULL THE VALVE. THE PHYSICIAN THAT S/HE FORGOT TO OPEN THE VALVE; HOWEVER, IT WAS NOTED TO BE OPEN. THE CASE WAS COMPLETED WITH NEW PRECISE (10-30). THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH WHEN IT WAS REMOVED FROM THE TRAY. THERE WAS NO DIFFICULTY ENCOUNTERED WHEN FLUSHING THE STOPCOCK. THERE WAS NO DIFFICULTY WHILE FLUSHING THE SDS. THE INTENDING PROCEDURE WAS A CAROTID ARTERY STENTING (CAS). THE INTENDED LESION WAS AT THE BIFURCATION. A NON-CORDIS 8F GUIDING CATHETER WAS USED. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING THE SDS TOWARDS THE LESION. UNUSUAL FORCE WAS NOT USED DURING THE PROCEDURE. NO DIFFICULTY OR RESISTANCE WAS EXPERIENCED WHEN CROSSING THE LESION. THE SDS DID NOT PASS THROUGH ANY PREVIOUSLY PLACES STENT. THE NEW STENT WAS DEPLOYED WITHOUT ANY ISSUES. THE DEVICE WILL BE RETURNED FOR ANALYSIS. ADDENDUM DUE TO PE FINDINGS: ADDED C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601170 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 4, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE STENT OF A PRECISE PRO RX 10MMX40MM NITINOL STENT SYSTEM COULD NOT BE DEPLOYED. THE PHYSICIAN TRIED TO LOOSEN THE VALVE AND DEPLOY THE STENT, BUT IT WAS TOO HARD TO PULL THE OUTER SHEATH AND COULD NOT BE DEPLOYED. THEREFORE, IT WAS REPLACED WITH A NEW 10MMX3MM PRECISE PRO AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE TO THE OUTER SHEATH NOTICED WHEN REMOVED FROM THE PATIENT. 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, INSPECTED, PREPPED, AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE PROCEDURE WAS A CAROTID ARTERY STENTING (CAS) OF THE RIGHT CAROTID ARTERY THAT HAD STENOSIS. THE LESION WAS FROM THE INTERNAL CAROTID ARTERY (ICA) TO THE COMMON CAROTID ARTERY (CCA). THE VESSEL HAD MODERATE TORTUOSITY. THE TARGET LESION VESSEL DIAMETER WAS 5-9MM. ACCESS WAS OBTAINED VIA LEFT INGUINAL REGION WITH A 6F NON CORDIS SHEATH. A 6F UNKNOWN GUIDE CATHETER WAS USED. A "FILTER WIRE" WAS PLACED AT THE DISTAL PORTION OF THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13449681 ↗

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