PRECISE PRO PC0730XCERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032062388), received between Dec 9, 2022 and Apr 30, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (7 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 30, 2026Difficult or Delayed Positioning

  AS REPORTED, A 7MM X 30MM PRECISE PRO CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM JAMMED WHEN OPENED. THERE WAS AN INDICATION THAT THE STENT WAS PARTIALLY DEPLOYED INSIDE THE PATIENT AND COULD NOT BE RELEASED. AFTERWORDS, THE ENTIRE STENT WAS RELEASED OUTSIDE OF THE PATIENT. SUBSEQUENTLY, A NEW 7MM X 30MM PRECISE PRO CAROTID SES DELIVERY SYSTEM WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE INTENDED LESION WAS CAROTID ARTERY STENTING (CAS). AT THE TARGET SITE, THERE WAS NO CALCIFICATION, MILD TORTUOSITY, 70% STENOSIS, AN ACUTE ANGLE, NO BIFURCATION, AND NO CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DAMAGE TO THE DEVICE PRIOR TO USE. THE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. DURING DEPLOYMENT, THE USER MAINTAINED A FIXED INNER SHAFT POSITION AND DID NOT APPLY EXCESS FORCE. THERE WAS NO DIFFICULTY REMOVING THE DELIVERY SYSTEM FROM THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25042741 ↗
• MalfunctionJun 14, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, DURING THE OPERATION "ANGIOPLASTY AND INTERNAL CAROTID ARTERY (ICA) STENTING," AFTER REMOVING THE 7.0MM X 30MM PRECISE PRO RX STENT SYSTEM FROM THE PROTECTIVE CASE, A DEFECT WAS DETECTED ¿ THE STENT WAS HALF RELEASED FROM THE DELIVERY SYSTEM (NORMALLY, IT SHOULD BE COMPLETELY INSIDE THE SYSTEM), AS A RESULT OF WHICH IT COULD NOT BE USED IN THE FUTURE. NEXT, ANOTHER 7.0MM X 40MM PRECISE PRO RX STENT SYSTEM WAS UNPACKED. DURING THE IMPLANTATION OF THE STENT INTO THE ICA STENOSIS ZONE, THE STENT WAS HALF RELEASED FROM THE DELIVERY SYSTEM, MULTIPLE ATTEMPTS WITH VARIOUS EFFORTS TO REMOVE THE STENT COMPLETELY WERE UNSUCCESSFUL (FACTORY DEFECT). NO VISUAL DEFECTS WERE DETECTED WHEN REMOVED FROM THE PROTECTIVE CASE. AS A RESULT, THE ONLY WAY TO REMOVE A COMPLETELY UNOPENED STENT FROM AN ARTERY IS TO SIMULTANEOUSLY REMOVE ALL INSTRUMENTS. THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER 7.0X40 MM PRECISE PRO RX STENT . THERE WERE NO REPORTS OF PATIENT INJURY. THE MANUFACTURER'S OUTER PACKAGING WAS VISUALLY UNDAMAGED FOR BOTH DEVICES. THE VESSEL CHARACTERISTICS AT THE TARGET SITE INCLUDED MILD CALCIFICATION, MILD TORTUOSITY, 90% STENOSIS, NO ACUTE ANGLE, NORMAL BIFURCATION, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208118 ↗
• MalfunctionMay 2, 2025Material Frayed; Peeled/Delaminated; Difficult to Remove; Material Split, Cut or Torn; Material Frayed; Peeled/Delaminated; Difficult to Remove; Material Split, Cut or Torn

  AS REPORTED, AFTER PLACING A 7MM X 30MM PRECISE PRO CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, AN ABNORMALITY WAS FELT WHEN RELEASING THE STENT. THERE WAS DIFFICULTY REMOVING THE DELIVERY SYSTEM FROM THE PATIENT, AND IT WAS REMOVED BY PINCHING THE SHEATH AND TAKING IT OUT. THE DEVICE WAS WITHDRAWN FROM THE BODY IN ONE PIECE; HOWEVER, IT WAS FOUND THAT THE DELIVERY SHEATH WAS SEPARATED NEAR THE STENT END. A NEW 7MM X 30MM PRECISE PRO CAROTID SES DELIVERY SYSTEM WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A CAROTID ARTERY DISSECTION IN WHICH A ROUTINE TRANSFEMORAL PUNCTURE WAS PERFORMED FOR ACCESS. THE VESSEL CHARACTERISTICS AT THE TARGET SITE INCLUDED MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DELIVERY SYSTEM WAS HELD FLAT AND STRAIGHT OUTSIDE OF THE PATIENT. THE STENT DID NOT PARTIALLY DEPLOY INSIDE THE PATIENT AND THERE WERE NO ATTEMPTS TO DEPLOY THE STENT AFTER IT WAS REMOVED FROM THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950367 ↗
• MalfunctionJan 30, 2025Difficult or Delayed Positioning; Material Frayed; Material Split, Cut or Torn; Difficult or Delayed Positioning; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, WHILE FLUSHING A 7MM X 30MM PRECISE PRO RX CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, IT WAS FOUND THAT THE ANTERIOR SECTION OF THE STENT HAD RELEASED 1-2MM. AN ATTEMPT TO ADVANCE THE OUTER SHEATH TO RETRACT THE STENT WAS MADE; HOWEVER, THIS CAUSED THE INNER SHAFT (GUIDEWIRE LUMEN) TO FRACTURE. THE INNER SHAFT (GUIDEWIRE LUMEN) FRACTURED BUT DID NOT SEPARATE INTO MULTIPLE PIECES. ANOTHER 7MM X 30MM PRECISE PRO RX SES DELIVERY SYSTEM WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE PRODUCT WAS STORED AND PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE, AND THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO DIFFICULTY FLUSHING THE DEVICE PRIOR TO OBSERVING THE PARTIAL RELEASE OF THE STENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275411 ↗
• MalfunctionDec 6, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, WHEN DELIVERING A 7 X 30 PRECISE PRO RX OUS CAROTID SYSTEM SELF-EXPANDING STENT (SES), THE STENT RELEASED EARLY. THE DEVICE DEPLOYED IN THE BIFURCATION OF THE INTERNAL CAROTID ARTERY WHILE BEING DELIVERED TO THE LESION. THE PROCEDURE WAS COMPLETED BY CHANGING TO AN UNKNOWN STENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES THAT WERE USED TO COMPLETE THE PROCEDURE WAS AN UNKNOWN CORDIS FILTER, UNKNOWN BALLOON AND UNKNOWN STENT. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE PRODUCT WAS NOT INSPECTED PRIOR TO USE AND WERE ANY ANOMALIES NOTED. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS NO ATTEMPT MADE TO RE-CAPTURE THE STENT. THE USER IS TRAINED TO THE DEVICE. THE PRODUCT WAS STORED AND PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865024 ↗
• MalfunctionAug 28, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 7X30 PRECISE PRO RX SELF-EXPANDING STENT (SES) PASSED THROUGH THE LESION. THE DEVICE WAS PULLED BACK INTO THE LESION IN PREPARATION FOR RELEASE, IT WAS FOUND THAT THE OUTER SHEATH COULD NOT BE RETRACTED, AND THE STENT COULD NOT BE RELEASED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DOCTOR WAS TRAINED IN USING THE DEVICE. THE INTENDED LESION WAS IN THE CAROTID ARTERY WHICH HAD A STENOSIS. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087243 ↗
• MalfunctionAug 16, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, AFTER INSERTING A 7MM X 30MM PRECISE PRO RX CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM INTO AN UNKNOWN 8F GUIDING SHEATH, THE DEVICE WAS UNABLE TO ADVANCE PAST THE PROXIMAL PORTION OF THE GUIDING SHEATH. UPON REMOVAL OF THE STENT, THE STENT OPENED BY ITSELF, OUTSIDE OF THE PATIENT. AS A RESULT, AN 8MM X 30MM PRECISE PRO RX SES DELIVERY SYSTEM WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A CAROTID ARTERY LESION DETECTED VIA ANGIOGRAPHY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO RESISTANCE EXPERIENCED WHILE REMOVING THE DEVICE. THE DEVICE HAS NOW BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555538 ↗
• MalfunctionApr 25, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THERE WAS RESISTANCE FELT WHEN PUSHING A 7MM X 30MM PRECISE PRO RX OUS CAROTID STENT DELIVERY SYSTEM (SDS) INTO THE UNKNOWN GUIDE CATHETER. THE SDS WAS PUSHED UNTIL IT REACHED THE HEAD END OF THE CATHETER, AT WHICH POINT THE SDS WAS UNABLE TO GO THROUGH THE CATHETER. THE DEVICE HAD INITIALLY BEEN FLUSHED AND THE PLAN WAS TO DELIVER THE STENT TO THE LESION WITH THE GUIDEWIRE. THE OPERATOR WITHDREW THE SDS AND FOUND A SPLIT AT THE TIP OF THE SHEATH, SO A NEW 7MM X 40MM PRECISE STENT WAS IMPLANTED INTO THE LESION. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER STENT SYSTEM. THERE WERE NO REPORTS OF PATIENT INJURY. THE PROCEDURE WAS A PERCUTANEOUS PUNCTURE CAROTID ARTERY STENT PLACEMENT CASE. AFTER AN 8F SHORT SHEATH WAS PLACED INTO THE FEMORAL ARTERY, AN UNKNOWN GUIDEWIRE AND AN UNKNOWN ANGIOGRAPHIC CATHETER WERE PLACED TO OBTAIN A VIEW OF THE AORTIC ARCH AND THE LEFT CAROTID ARTERY RESPECTIVELY. IT SHOWED STENOSIS OF THE BEGINNING SEGMENT OF THE INTERNAL CAROTID ARTERY. A 7F MPA GUIDING CATHETER WAS REPLACED, A CEREBRAL PROTECTION DEVICE WAS PLACED IN THE DISTAL INTERNAL CAROTID ARTERY, AND A 7 MM DIAMETER AND 30 MM LENGTH PRECISE CAROTID STENT WAS ATTEMPTED TO BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811342 ↗
• MalfunctionDec 9, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, PART OF A PRECISE PRO RX 7X30 SELF-EXPANDING STENT (SES) HAD BEEN RELEASED BEFORE IT WAS TAKEN OUT FROM THE TRAY. THE USER TRIED TO USE THE RELEASE SHEATH TO TIGHTEN IT, BUT IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN STENT. THERE WAS NO REPORTED PATIENT INJURY. THE MALFUNCTION OCCURRED DURING PREP. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS OPENED IN A STERILE FIELD. THE USER IS TRAINED TO THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950726 ↗