Transend™ EX M001468060Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08714729201212), received between May 17, 2016 and Jan 16, 2025 — classified as 3 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE TIP BROKE DURING THE PROCEDURE AND WAS REMOVED WITH THE SNARE DEVICE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175629 ↗
• MalfunctionSep 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDEWIRE WAS POSITIONED IN THE CEREBRAL VASCULATURE. THE SUBJECT GUIDEWIRE DID NOT GENERATE DISTAL TORQUE, SO AN ATTEMPT WAS MADE TO REMOVE IT, BUT IT GOT STUCK IN THE VESSEL. AS A RESULT, THE ENTIRE SYSTEM HAD TO BE REMOVED, AND THE ACCESS ROUTE WAS LOST TO PREVENT THE GUIDEWIRE FROM MIGRATING. THE FLOPPY PORTION OF THE SUBJECT GUIDEWIRE GOT DETACHED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181239 ↗
• MalfunctionJul 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ENDOVASCULAR PROCEDURE, MULTIPLE ATTEMPTS WERE MADE TO GAIN DISTAL ACCESS BY THE PHYSICIAN. SUDDENLY THE DISTAL TIP OF THE SUBJECT GUIDEWIRE GOT FRACTURED INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244142 ↗
• MalfunctionJun 19, 2023Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELING. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17150367 ↗
• MalfunctionApr 11, 2023Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE GUIDEWIRE (SUBJECT DEVICE) PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS SEEN TO BE PEELING . NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710880 ↗
• InjuryMar 15, 2023Fracture; Fracture

  IT WAS REPORTED DURING AN INTRA-ARTERIAL THROMBECTOMY (IAT) PROCEDURE THE TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN OFF IN THE CAROTID SIPHON. THE BROKEN FRAGMENT OF THE SUBJECT GUIDEWIRE WAS ATTEMPTED TO BE REMOVED WITH A SNARE DEVICE BUT WAS UNSUCCESSFUL. ASPIRATION WITH A CATHETER WAS ALSO ATTEMPTED TO REMOVE THE BROKEN FRAGMENT BUT WAS ALSO UNSUCCESSFUL. THE SUBJECT GUIDEWIRE TIP MIGRATED TO THE M1 SEGMENT AND WAS LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF UNKNOWN TIME, AND THE PROCEDURE WAS NOT COMPLETED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16550042 ↗
• MalfunctionFeb 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE DISTAL TIP OF THE SUBJECT GUIDEWIRE BROKE WHILE INSERTING THE GUIDEWIRE INTO THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326789 ↗
• MalfunctionNov 23, 2021Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PTFE COATING OF THE SUBJECT GUIDEWIRE WAS PEELED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866371 ↗
• MalfunctionAug 13, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322038 ↗
• MalfunctionJun 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) IT WAS BROKEN DURING THE PROCEDURE CAUSING A SURGICAL DELAY OF TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081585 ↗
• MalfunctionJun 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE THE GUIDEWIRE (SUBJECT DEVICE) WAS IN THE MICROCATHETER AND IT WAS BEING TORQUED, THE TIP OF THE SUBJECT GUIDEWIRE BROKE OFF IN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942267 ↗
• MalfunctionApr 24, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE A FOREIGN MATERIAL WAS FOUND DUE TO THE PTFE (POLYTETRAFLUOROETHYLENE) OF THE SUBJECT GUIDEWIRE PEELING WHEN INSERTED AND REMOVED FROM THE MICROCATHETER. THE FOREIGN MATERIAL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721647 ↗
• MalfunctionApr 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING AIS (ACUTE ISCHEMIC STROKE) TREATMENT, THE TIP OF THE SUBJECT GUIDEWIRE WAS CUT OFF. THE MICROCATHETER WAS USED TO REMOVE THE DETACHED TIP FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631726 ↗
• MalfunctionMar 16, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE GUIDEWIRE (SUBJECT DEVICE) WAS INSERTED INTO THE CATHETER THERE WAS RESISTANCE. WHEN REMOVED AND EXAMINED, THE SUBJECT GUIDEWIRE COATING APPEARED TO BE PEELING. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496200 ↗
• MalfunctionFeb 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDEWIRE WAS SHAPED TO 45 DEGREE AND WAS DELIVERED ALONG WITH MICROCATHETER TO PASS THE LESION DURING A MCA (MIDDLE CEREBRAL ARTERY) STENOSIS. THE PHYSICIAN NOTED THAT THE TIP OF THE GUIDEWIRE WAS NOT ABLE TO BE TORQUED. WHILE UNDER FLUOROSCOPY FOUND THAT THE SUBJECT GUIDEWIRE HAD FRACTURED WITHIN MICROCATHETER AND CONFIRMED A DISTAL TIP FRACTURE UPON REMOVAL OF PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO NOTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298905 ↗
• InjuryDec 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT A PROCEDURE FOR STENT-ASSISTED COIL EMBOLIZATION FOR ACOM (ANTERIOR COMMUNICATING ARTERY) CEREBRAL ANEURYSM WAS PERFORMED. WHILE OPERATING SUBJECT GUIDEWIRE AT ACA (ANTERIOR CEREBRAL ARTERY), IT WAS NOTED TO BE BROKEN AT 4CM TO 5CM FROM THE TIP AND REMAINED WITHIN PATIENT ANATOMY. THE FRACTURED PORTION OF THE SUBJECT GUIDEWIRE WAS AT THE ACOM PENETRATING BRANCH TO THE INTERNAL CAROTID ARTERY C3. PHYSICIAN TRIED TO REMOVE IT BY USING A RECOVERY SNARE TO CAPTURE THE PROXIMAL END. THE RETRIEVAL WAS UNSUCCESSFUL AFTER THE FRAGMENTED PIECE ENTERED THE OPHTHALMIC ARTERY. AT THIS POINT THE STUMP END OF THE SUBJECT DEVICE WAS LOCATED FROM THE ACOM PENETRATING BRANCH TO THE OPHTHALMIC ARTERY, AND IT WAS JUDGED THAT THE RISK OF INVASION TO THE PERIPHERY OF THE CEREBRAL ARTERY WAS REDUCED, AND CEREBRAL ANEURYSM COIL EMBOLIZATION WAS PERFORMED. PHYSICIAN THEN PLACED A STENT TO COVER THE DISTAL STUMP AND ACOM ANEURYSM NECK. E2 WAS PLACED FROM C1 TO C3 FOR THE PROXIMAL END, AND THE STUMP WAS FIXED TO THE VESSEL WALL. SURGICAL DELAY DUE TO THIS EVENT WAS NOTED TO BE 240 MINUTES. THE DAY AFTER THE OPERATION, MRI CONFIRMED A SMALL INFARCT IN THE MOTOR CORTEX (JUST AT THE BOUNDA

  Patient problems: Foreign Body In Patient; Stroke/CVA

  MAUDE report 11061381 ↗
• MalfunctionDec 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A BA (BASILAR ARTERY) ANEURYSM CASE, PHYSICIAN USED SUBJECT GUIDEWIRE TO WORK WITH MICROCATHETER TO REACH TARGET LOCATION. THE CASE WAS VERY COMPLICATED, AND THE VERTEBRAL ARTERY (VA) WAS VERY TORTUOUS, SO IT WAS DIFFICULT TO SET THE SUBJECT GUIDEWIRE TO THE TARGET POINT. DURING THE DELIVERY OF THE SUBJECT GUIDEWIRE, FRICTION WAS ENCOUNTERED, AND THE DISTAL TIP FRACTURED AT THE CONNECTION OF VA AND BA. PHYSICIAN WITHDREW THE SUBJECT DEVICE AND USED THE MICROCATHETER TO REMOVE THE FRACTURED PART. THE PHYSICIAN PROCEEDED TO USE A SECOND SIMILAR GUIDEWIRE, HOWEVER THE SAME EVENT OCCURRED. THE FRACTURED PIECE WAS REMOVED THROUGH ASPIRATION. THE PHYSICIAN REPLACED IT WITH A NEW SIMILAR DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11060716 ↗
• MalfunctionJul 8, 2020Peeled/Delaminated; Peeled/Delaminated

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THERE WAS SOME SLIGHT DAMAGE AND PEELING NOTED TO THE PTFE COATING AT THE PROXIMAL END DUE TO A TORQUE DEVICE USED DURING MANIPULATION OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10247737 ↗
• MalfunctionMay 29, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN INSERTING THE COIL INTO MICROCATHETER AND PUSHED IT OUT SEVERAL TIMES WITH THE GUIDEWIRE (SUBJECT DEVICE), THE RESISTANCE WAS ENCOUNTERED; THEREFORE, THE GUIDEWIRE (SUBJECT DEVICE) WAS WITHDRAWN AND FOUND THAT THE GUIDEWIRE'S TIP (SUBJECT DEVICE) WAS DISCONNECTED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10103196 ↗
• MalfunctionMay 10, 2019Break; Break

  DURING EMBOLIZATION PROCEDURE OF INTERNAL CAROTID ARTERY (ICA) ANEURYSM, IT WAS REPORTED THAT THE RESISTANCE WAS FELT DURING INSERTION OF THE GUIDEWIRE (SUBJECT DEVICE) INTO THE NON-STRYKER MICROCATHETER, THEN MORE FORCE WAS APPLIED TO PUSH IN THE GUIDEWIRE WHICH CAUSED THE GUIDEWIRE TO BE KINKED AND BROKEN AT THE PROXIMAL PART OF THE GUIDEWIRE. THE BROKEN GUIDEWIRE WAS REMOVED SAFELY FROM THE PATIENT WITHOUT ANY ADVERSE CONSEQUENCES. THE PROCEDURE WAS COMPLETED WITH A NEW SET AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600861 ↗
• InjuryDec 27, 2018Break; Break

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF AN ANEURYSM LOCATED AT THE RIGHT CAVERNOUS INTERNAL CAROTID ARTERY (ICA), A GUIDEWIRE (SUBJECT DEVICE) TOGETHER WITH A MICROCATHETER WERE ADVANCED WITHIN THE VASCULATURE. THE PHYSICIAN TRIED TO LOOP THE WIRE IN THE ANEURYSM SAC IN ORDER TO TRY TO GET ACROSS THE NECK OF THE ANEURYSM. THE 3CM GUIDEWIRE TIP BROKE OFF INSIDE THE ANEURYSM. THE PHYSICIAN REALIZED THAT THE GUIDEWIRE BROKE WHEN HE WANTED TO DO A RUN AFTER WITHDRAWING THE GUIDEWIRE FROM THE MICROCATHETER AND HE NOTICED THAT THERE WAS NO FLOW OF FLUSHING. THE PHYSICIAN PLANNED TO USE A SNARE DEVICE TO RETRIEVE THE BROKEN PART OF THE GUIDEWIRE BUT SEEING THE TORTUOSITY OF THE VESSEL, HE DECIDED TO SACRIFICE THE VESSEL BY DEPLOYING A DETACHABLE BALLOON. AFTER BALLOON DEPLOYMENT, THERE IS STILL GOOD COLLATERAL BLOOD FLOW INTO THE RIGHT SIDE OF BRAIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8199855 ↗
• MalfunctionDec 21, 2018Break; Peeled/Delaminated; Break; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT DEVICE GUIDEWIRE WAS BROKEN AND THE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS PEELED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188652 ↗
• MalfunctionDec 17, 2018Break; Break

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE WAS NOTED TO BE FRACTURED IN THE MIDDLE SUDDENLY INSIDE THE PATIENT WITHOUT ANY TOUGH MOVEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE FOR NOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171672 ↗
• MalfunctionOct 3, 2018Break; Break

  IT WAS REPORTED THAT THE GUIDEWIRE BROKE ON ITS PROXIMAL PART DURING THE PROCEDURE. THERE WERE NO CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930963 ↗
• MalfunctionSep 17, 2018Peeled/Delaminated; Peeled/Delaminated

  BASED ON THE INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE GUIDEWIRE PTFE COATING WAS SCRAPPED OFF. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881997 ↗