Cordis PRECISE PRO Rx Nitinol Stent System PC0940RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032036525), received between Nov 1, 2016 and Nov 30, 2023 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9 most recent of 9 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 27, 2022Retraction Problem; Difficult to Open or Close; Therapeutic or Diagnostic Output Failure

  STENT WOULD NOT OPEN, SHEATH NOT RETRACTED DUE TO DEVICE FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 13365992 ↗
• InjuryMar 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 9MM X 40MM PRECISE PRO CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS IMPLANTED; HOWEVER, WHEN THE PHYSICIAN RETRACTED THE UNIT, THERE WAS NO DISTAL TIP ON IT. A NON-CORDIS GUIDING CATHETER PUSHED THE UNKNOWN FILTER AND THE DISTAL TIP OF THE PRECISE PRO WAS REMOVED WITH THE NON-CORDIS GUIDING CATHETER. THE STENT WAS IMPLANTED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393422 ↗
• InjuryOct 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 9MM X 40MM PRECISE PRO RAPID EXCHANGE (RX) CAROTID STENT SYSTEM WAS TRIED TO BE IMPLANTED. HOWEVER, SOMETHING LOOKS LIKE THE STENT DELIVERY SYSTEM (SDS) TIP WAS AT THE DISTAL END OF THE UNKNOWN BALLOON CATHETER UNDER FLUOROSCOPY. THE PHYSICIAN REMOVED THE PRECISE PRO AND FOUND THAT IT DID NOT HAVE ITS TIP; THEREFORE, HE PERFORMED POST DILATION USING THE UNKNOWN BALLOON CATHETER THEN REMOVED IT. SOMETHING LIKE THE SDS TIP WAS REMOVED FROM THE PATIENT USING AN UNKNOWN FILTER WIRE. NOTHING REMAINED INSIDE THE PATIENT. AN UNKNOWN STENT WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT SUFFER FROM ANY COMPLICATIONS. THIS WAS A CAROTID ARTERY STENTING (CAS) CASE. THE LESION WAS THE RIGHT CAROTID ARTERY. A NON-CORDIS 8F GUIDING CATHETER, NON-CORDIS GUIDEWIRE, NON-CORDIS Y CONNECTOR WERE DELIVERED TO THE LESION AND THE STENT DELIVERY SYSTEM WAS ASSEMBLED. AN UNKNOWN 4MM BALLOON CATHETER WAS USED AS PRE DILATION THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10635818 ↗
• MalfunctionMar 24, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A 9X40 PRECISE PRO RAPID EXCHANGE (RX) CAROTID STENT COULD NOT BE DEPLOYED. THEREFORE, IT WAS REPLACED WITH A NEW 10/40MM PRECISE PRO AND THE NEW DEVICE COULD BE DEPLOYED AND IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND DURING FAL, THE STENT WAS PARTIALLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A CAROTID ARTERY STENTING (CAS) CASE. THE LESION WAS THE RIGHT CAROTID ARTERY WHICH HAS STENOSIS. 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. THE LESION INCLUDED THE COMMON CAROTID ARTERY TO INTERNAL CAROTID ARTERY. AN APPROACH WAS MADE FROM THE INGUINAL REGION WITH A NON-CORDIS 8F GUIDING SHEATH AND ADVANCED TO THE COMMON CAROTID ARTERY. THE INTENDED LESION WAS CALCIFIED. THE LESION HAS MODERATE CALCIFICATION BUT THERE IS NO VESSEL TORTUOSITY. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. THE DELIVERY OF THE SDS TO THE LESION WAS IPSILATERAL. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. AFTER FILTERING T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9872044 ↗
• MalfunctionFeb 15, 2018Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove

  DURING USE, THE DISTAL TIP OF THE PRECISE PRO STENT WAS CAUGHT ON A CATHETER AND THEN IT SEPARATED. THERE WAS NO PATIENT INJURY. THE SEPARATED DISTAL TIP WAS ON THE GUIDEWIRE, THEREFORE, IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE COMPLETED SUCCESSFULLY. A PRECISE PRO WAS DELIVERED TO THE LESION AND IMPLANTED. WHEN THE DELIVERY SYSTEM WAS REMOVED, THE DISTAL TIP GOT CAUGHT BY THE EXIT PORT OF A SUPPORT NON CORDIS CATHETER. THE PHYSICIAN PULLED IT WITH SOME FORCE, THEN THE DISTAL TIP SEPARATED. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7273427 ↗
• MalfunctionNov 1, 2016Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE PRECISE PRO RX US CAROTID STENT DELIVERY SYSTEM (SDS) WOULD ONLY OPEN ABOUT 30%, THEREFORE THE PHYSICIAN COULD NOT GET THE DEVICE TO OPEN ALL THE WAY. THERE WAS NO PATIENT INJURY. THE PHYSICIAN REMOVED THE DEVICE, REPLACED IT WITH ANOTHER PRECISE PRO 8 X 40 AND COMPLETED THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED. THERE WAS NO OTHER PRODUCT ISSUE NOTED EITHER AT THE ACCOUNT, AFTER THE PROCEDURE, OR PRIOR TO SHIPPING FOR INSPECTION. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO TORTUOSITY ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE/DURING MANIPULATION, OR ANY REPORTED DIFFICULTY ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE PRODUCT WAS STORED IN THE LAB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6069229 ↗

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)