Cordis PRECISE PRO Rx Nitinol Stent System PC1040RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20705032036556), received between Mar 14, 2017 and Sep 24, 2022 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• MalfunctionDec 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN INTERVENTIONAL PROCEDURE, THERE WAS DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING A 10X40 PRECISE PRO RX STENT SDS TOWARDS THE LESION. IT WAS DELIVERED TO THE LESION BUT "WHEN THE STENT WAS RELEASED , THERE WAS STRONG RESISTANCE. THEREFORE, IT WAS REPLACED WITH A NEW PRECISE (9MMX40MM) AND IT COULD BE IMPLANTED WITHOUT RESISTANCE AND ISSUE. ANALYSIS OF THE RETURNED DEVICE INDICATED PARTIAL STENT DEPLOYMENT. THE BIFURCATION ANGLE FROM THE COMMON CAROTID ARTERY TO THE INTERNAL CAROTID ARTERY WAS TIGHT." THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A CAROTID ARTERY STENTING. THE TARGET LESION WAS THE INTERNAL CAROTID ARTERY (ICA) TO COMMON CAROTID ARTERY (CCA). THE TARGET LESION VESSEL DIAMETER WAS 6MM IN THE ICA AND 8MM IN THE CCA. THE TARGET LESION VESSEL LENGTH WAS LITTLE LESS THAN 3 CM. THERE WAS ALMOST NO CALCIFICATION AND VESSEL TORTUOSITY. 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, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12952471 ↗
• InjuryFeb 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 10MM X 40MM PRECISE PRO RAPID EXCHANGE (RX) CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS IMPLANTED. AFTER THAT, A 3 X 40MM NON-CORDIS BALLOON CATHETER WAS INSERTED TO BE INFLATED AS POST DILATION. HOWEVER, DURING DELIVERY TO THE LESION, THERE WAS RESISTANCE. WHEN CHECKED UNDER FLUOROSCOPY, SOMETHING LIKE TIP OF THE PRECISE PRO RX WAS CONFIRMED. THE SHAFT OF THE PRECISE PRO RX WAS CHECKED OUTSIDE THE BODY AND CONFIRMED THAT THERE WAS NO TIP AT THE DISTAL END. THE UNKNOWN GUIDEWIRE WAS DEFLATED AT 2-3MM, THE TIP WAS PUT INTO A NON-CORDIS GUIDING CATHETER. THE GUIDING CATHETER WAS REMOVED FROM THE PATIENT BODY AND THE TIP OF THE PRECISE PRO WERE SUCCESSFULLY REMOVED. AFTER THAT, THE NON-CORDIS GUIDING CATHETER WAS IMPLANTED AGAIN AT THE COMMON CAROTID ARTERY. THE UNKNOWN GUIDEWIRE WAS IMPLANTED AT THE DISTAL LESION AND INFLATED AT 5MM. A 4 X 30MM NON-CORDIS BALLOON CATHETER WAS INFLATED AS POST DILATION AND ASPIRATED WITH A SUCTION CATHETER. GOOD DILATION WAS CONFIRMED BY CONTRAST ENHANCEMENT, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY. INITIALLY, THE TARGET LESION WAS THE LEFT CAROTID ARTERY WHICH HAS STENOSIS. THE LEFT COMMON CAROTID ARTERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386215 ↗
• InjuryFeb 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PRECISE PRO RAPID EXCHANGE (RX) SES (SELF-EXPANDING STENT) DELIVERY SYSTEM WAS USED AT THE LESION FROM THE COMMON CAROTID ARTERY TO INTERNAL CAROTID ARTERY; HOWEVER, THE PHYSICIAN NOTICED SOMETHING WAS THERE WHEN THEY ATTEMPTED TO REMOVE AN EMBOLIC PROTECTION TOOL (NON-CORDIS). THE PHYSICIAN ATTEMPTED TO REMOVE IT BY USING A CATHETER FOR REMOVING OR AN INNER GUIDING CATHETER (NON-CORDIS), BUT IT WAS DIFFICULT. IT WAS REPLACED WITH A GUIDING SHEATH (8F, NON-CORDIS). IT WAS ABLE TO REMOVE THE OBJECT. IT WAS RECOGNIZED THAT IT WAS THE TIP OF THE PRECISE PRO. IT WAS CONFIRMED THAT THERE WERE NO PROTRUSIONS BY A POST- INTRAVASCULAR ULTRASOUND (IVUS). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO REPORTED PATIENT INJURY. THIS WAS A CAROTID ARTERY STENTING (CAS) CASE. THE LESION WAS NOT SEVERELY CALCIFIED THERE WAS NO VESSEL TORTUOSITY. THERE WAS MINIMAL ANGULATION OF THE TARGET VESSEL WITH A 70-80% STENOSIS. THE DEVICE WAS NOT RE-STERILIZED. THE DEVICE WAS STORED, PREPPED, AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE AND NO ANOMALIES NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11315162 ↗
• InjuryJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE INNER SHAFT OF A 10MM X 40MM PRECISE PRO CAROTID SELF-EXPANDING STENT DELIVERY SYSTEM GOT SEPARATED, AND THE DISTAL TIP WAS DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. INITIALLY, A NON-CORDIS EMBOLIC PROTECTION SYSTEM WAS BEING REMOVED BUT THE FILTER WAS NOT ABLE TO BE RETRACTED INTO THE PRECISE PRO. THE PHYSICIAN USED ANGIOGRAPHY, WHICH SHOWED THE PRECISE PRO TIP. THE TIP WAS CONFIRMED IN THE IMAGE WHEN THE CATHETER WAS BROUGHT IN TO REMOVE THE NON-CORDIS FILTER. THEREFORE, IT WAS CONSIDERED THAT THE TIP GOT SEPARATED AND DAMAGED IN THE GUIDING CATHETER. THEREFORE, THE 8F GUIDING CATHETER (UNKNOWN) WAS GUIDED UP AND WAS REMOVED. THE PRECISE PRO TIP WAS FOUND ON THE REMOVED NON-CORDIS EMBOLIC PROTECTION SYSTEM. THE STENT WAS IMPLANTED AFTER THE PROCEDURE WAS COMPLETED. THE FLUOROSCOPIC IMAGE WHICH WAS TAKEN WHEN THE PRECISE PRO WAS REMOVED, CONFIRMED THAT THE TIP OF THE PRECISE PRO WAS ATTACHED TO THE NON-CORDIS EMBOLIC PROTECTION SYSTEM. THERE WAS NO RESISTANCE FELT WHEN THE SDS WAS REMOVED. THERE WERE NO COMPLICATIONS FOR THE PATIENT AFTER THE PROCEDURE. NO PROBLEMS WERE IDENTIFIED WITH THE PRECISE PRO BEFORE OR DURING USE. THE SEPARATED DISTAL END OF THE TIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162946 ↗
• InjuryOct 14, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A 10 X 30 PRECISE PRO RX CAROTID SELF-EXPANDING STENT (SES) STENT RELEASED IN THE PATIENT WHILE ACCESSING THE FEMORAL ARTERY PUNCTURE SITE AND DEPLOYED IN THE FEMORAL ARTERY WHICH LED TO A MASSIVE HEMORRHAGE. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND PERFORMED COMPRESSION HEMOSTASIS FOR THE PUNCTURE POINT. THEN A LARGE SIZE BALLOON WAS USED TO BLOCK THE BLOOD FLOW AND THE STENT WAS REMOVED. THE ARTIFICIAL BLOOD VESSEL WAS USED FOR THE FOLLOWING HEMOSTASIS WHICH WAS COMPLETED SUCCESSFULLY. NO FURTHER PROCEDURE WAS DONE FOR THE LEFT SUBCLAVIAN SO THERE WAS NO ANOTHER STENT TO TREAT THE LEFT SUBCLAVIAN. THE INTENDED PROCEDURE WAS TO TREAT THE LEFT SUBCLAVIAN STENOSIS. THE 50% OCCLUDED TARGET LESION WAS 26MM IN LENGTH IN A 9MM VESSEL DIAMETER. THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY. 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, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WAS NO UNUSUAL FORCE U

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10677115 ↗
• InjuryMay 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, FOLLOWING THE STENT DEPLOYMENT, THE DISTAL END OF A PRECISE PRO RX GOT SEPARATED WHEN THE PHYSICIAN REMOVED IT, FEELING SLIGHT RESISTANCE. THE SEPARATED FRAGMENTS WERE REMOVED FROM THE PATIENT¿S BODY WITH A GOOSENECK WIRE. THE DOCTOR COMMENTED THAT THIS ISSUE MIGHT HAVE CAUSED BY RESIDENCE FROM EXTRANEOUS FACTORS. THERE WAS NO REPORTED PATIENT INJURY AND THE PROCEDURE WAS COMPLETED. THE TARGET LESION WAS THE INTERNAL CAROTID ARTERY. THE PRECISE PRO WAS USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. THERE WAS NO ANOMALIES CONFIRMED ON THE DEVICE PRIOR TO AND DURING THE PROCEDURE. INITIALLY, A BALLOON CATHETER WAS INFLATED, A GUIDEWIRE AND THE PRECISE PRO RX WAS INSERTED AND IMPLANTED. THE DEVICE WAS STORED AS PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE TO THE LESION. THE SEPARATED PART OF THE DEVICE WAS LESS THAN 1-CENTIMETRES (CM) AT DISTAL END TIP PART ONLY. THE SEPARATED DISTAL END(S) WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 8624702 ↗
• MalfunctionMay 14, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, A PRECISE PRO WAS PREPPED AND WAS ATTEMPTED TO BE INSERTED ALONG A GUIDEWIRE, HOWEVER, IT WAS CONFIRMED THAT THE DISTAL TIP OBVIOUSLY SWELLED. THE THICKNESS INCREASED BY APPROXIMATE 20 PERCENT AND IT CAME IN FRONT OF THE OUTER MEMBER. THERE WAS NO REPORTED PATIENT INJURY. IT WAS REPLACED WITH A NEW DEVICE AND THE PROCEDURE WAS CONTINUED. THE PRECISE PRO WAS COMPARED WITH ANOTHER PRECISE PRO WHICH WAS USED FOR ANOTHER PROCEDURE AND THE THICKNESS WAS CONFIRMED. THERE WAS RESISTANCE FELT WHEN A GUIDEWIRE WAS INSERTED. DURING THE PRODUCT EVALUATION, IT WAS CONFIRMED THAT A RIP/TEAR WAS OBSERVED ON THE OUTER MEMBER TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609216 ↗
• MalfunctionFeb 27, 2018Material Frayed; Difficult to Advance; Torn Material; Material Frayed; Difficult to Advance; Torn Material

  DURING USE, IT WAS REPORTED THAT A PRECISE PRO STENT DID NOT COVER THE LESION. ANOTHER PRECISE PRO STENT WAS USED AND DURING ADVANCEMENT THROUGH THE FIRST STENT, THE DELIVERY SYSTEM WAS CAUGHT BY THE PROXIMAL EDGE OF THE FIRST STENT. THE PRECISE PRO STENT DELIVERY SYSTEM WAS REMOVED, AND THE FIRST WAS DILATED BY A BALLOON CATHETER (5MM). THE COMPLAINT STENT WAS INSERTED AGAIN, BUT IT WAS CONFIRMED THAT THE DISTAL END OF THE OUTER SHEATH WAS FRAYED. THERE WAS NO REPORTED PATIENT INJURY. THEREFORE THE SECOND PRECISE STENT WAS REPLACED WITH A NEW UNKNOWN STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS THE ORIGIN OF THE LEFT INTERNAL CAROTID ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE STENOSED LENGTH WAS OVER 2 CM. THE INTERNAL DIAMETER OF THE VESSEL WAS 9 MM. THE CONCOMITANT GUIDEWIRE WAS A NON CORDIS WIRE AND THE CONCOMITANT GUIDING CATHETER WAS NON CORDIS GUIDE CATHETER. A PRECISE PRO (10MM*4CM) WAS DELIVERED TO THE LESION AND IMPLANTED FROM THE LEFT COMMON CAROTID ARTERY TO THE LEFT INTERNAL CAROTID ARTERY. THEN THE DISTAL LESION WAS NOT COVERED. THE PRODUCT WAS CLINICALLY USED. AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7299275 ↗
• InjuryFeb 27, 2018Defective Component; Defective Component

  DURING USE, IT WAS REPORTED THAT A PRECISE PRO STENT DID NOT COVER THE LESION. ANOTHER PRECISE PRO STENT WAS USED AND DURING ADVANCEMENT THROUGH THE FIRST STENT, THE DELIVERY SYSTEM WAS CAUGHT BY THE PROXIMAL EDGE OF THE FIRST STENT. THE PRECISE PRO STENT DELIVERY SYSTEM WAS REMOVED, AND THE FIRST WAS DILATED BY A BALLOON CATHETER (5MM). THE COMPLAINT STENT WAS INSERTED AGAIN, BUT IT WAS CONFIRMED THAT THE DISTAL END OF THE OUTER SHEATH WAS FRAYED. THERE WAS NO REPORTED PATIENT INJURY. THEREFORE THE SECOND PRECISE STENT WAS REPLACED WITH A NEW UNKNOWN STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS THE ORIGIN OF THE LEFT INTERNAL CAROTID ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE STENOSED LENGTH WAS OVER 2 CM. THE INTERNAL DIAMETER OF THE VESSEL WAS 9 MM. THE CONCOMITANT GUIDEWIRE WAS A NON CORDIS WIRE AND THE CONCOMITANT GUIDING CATHETER WAS NON CORDIS GUIDE CATHETER. A PRECISE PRO (10MM*4CM) WAS DELIVERED TO THE LESION AND IMPLANTED FROM THE LEFT COMMON CAROTID ARTERY TO THE LEFT INTERNAL CAROTID ARTERY. THEN THE DISTAL LESION WAS NOT COVERED. THE PRODUCT WAS CLINICALLY USED. AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7299225 ↗
• MalfunctionJul 20, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED, DURING A CAROTID STENTING PROCEDURE THE PRECISE PRO RX CATHETER SPLIT APART WHILE TRYING TO POSITION THE STENT DEVICE IN THE TRANVERSE VENOUS SINUS. THE ENTIRE DEVICE WAS ABLE TO BE REMOVED AND ANOTHER CATHETER WAS USED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS NOT USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS EASILY REMOVED FROM THE PATIENT INTACT (IN ONE PIECE). THEN, A NEW PRECISE STENT WAS REINSERTED AND DEPLOYED WITH NO DIFFICULTY. THE PROCEDURE WAS FINISHED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6730511 ↗
• MalfunctionJun 13, 2017Crack; Crack

  THE REPORT RECEIVED INDICTED THAT DURING A CAROTID ARTERY STENTING (CAS) PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE PRECISE PRO RX 10 X 40 STENT DELIVERY SYSTEM (SDS) OVER THE UNKNOWN GUIDEWIRE AND A CRACK OF THE SDS DISTAL TIP WAS NOTED. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.  THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS UNKNOWN AND NO TARGET LESION CHARACTERISTIC INFORMATION WAS PROVIDED. THE APPROACH FOR THE PROCEDURE WAS FEMORAL. THE REPORTED PRODUCT ISSUE OCCURRED AFTER PRE-DILATION USING A NON-CORDIS BALLOON CATHETER AND AN UNKNOWN GUIDING CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS UNKNOWN IF THE GUIDEWIRE USED WAS A CORDIS PRODUCT. THERE WAS NO REPORTED PRODUCT ISSUE WITH THE GUIDEWIRE USED. IT WAS NOT KNOWN IF THE SAME GUIDEWIRE WAS USED SUBSEQUENTLY WITH OTHER DEVICES OR IF THE CRACK REPORTED WAS TO THE DISTAL TIP, DEPLOYMENT SHEATH, OR STENT DELIVERY SYSTEM (SDS). 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. THER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6636921 ↗
• MalfunctionMar 14, 2017Detachment Of Device Component; Difficult or Delayed Positioning; Detachment Of Device Component; Difficult or Delayed Positioning

  IT WAS REPORTED THAT A PRECISE STENT WAS ATTEMPTED TO BE DEPLOYED AFTER PRE-DILATATION, HOWEVER IT WAS UNABLE TO BE DEPLOYED UNDER FLUOROSCOPY EVEN THOUGH THE OUTER SHEATH WAS WITHDRAWN AND THE INNER SHAFT WAS FIXED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS PREPPED PER THE IFU AND THERE WERE NO ANOMALIES NOTED DURING PREP. WHEN THE SYSTEM WAS REMOVED FROM THE PATIENT, IT WAS CONFIRMED THAT THE STENT SHAFT WAS SEPARATED. THE DEVICE WAS REPLACED WITH ANOTHER ONE OF A SMALLER SIZE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6404847 ↗

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)