Transend EXRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 4 models of Transend EX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 93 adverse event reports in the FDA's MAUDE database, received between May 17, 2016 and Jan 16, 2025 — classified as 7 injuries, 86 malfunctions.
The most frequently reported specific device problem is “Break” (34 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
Reports received per month, all models
Most reported Transend EX problems
Device problems
- Break34
- Peeled/Delaminated34
- Fracture28
- Material Integrity Problem2
- Device Contamination with Chemical or Other Material1
- Unclear Information1
Patient problems
- No Consequences Or Impact To Patient47
- No Clinical Signs, Symptoms or Conditions32
- No Patient Involvement7
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient2
- Stroke/CVA2
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
Transend EX models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Transend™ EX M001468060WIRE, GUIDE, CATHETER37 reports
- Transend™ EX M001468070WIRE, GUIDE, CATHETER23 reports
- Transend™ EX M001468050WIRE, GUIDE, CATHETER20 reports
- Transend™ EX M001468080WIRE, GUIDE, CATHETER13 reports
Recent Transend EX adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 11, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING THE PREPARATION, SMALL DETACHED FRAGMENTS FROM THE SUBJECT GUIDEWIRE BECAME DETACHED BEFORE IT WAS INSERTED INTO THE MICROCATHETER. 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 18874245 ↗MalfunctionFeb 23, 2024Fracture; Fracture
IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT GUIDEWIRE TIP DETACHED INSIDE THE CATHETER DURING REMOVAL FROM THE PATIENT. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18768968 ↗MalfunctionDec 5, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING ONE MIDDLE CEREBRAL ARTERY MCA STENOSIS CASE, WHEN USING SUBJECT GUIDEWIRE TO BUILD ACCESS, FRICTION WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT GUIDEWIRE INTO MICROCATHETER. WITHDREW THE GUIDEWIRE AND FOUND COATING OF THE TIP WAS PEELED OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18267399 ↗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 20, 2023Peeled/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 AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16781676 ↗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 ↗InjuryDec 7, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A COMPLEX INTRACEREBRAL THROMBECTOMY PROCEDURE , THE THIRD PROBING MANEUVER WITH A GUIDEWIRE (SUBJECT DEVICE) RESULTED IN THE FRACTURE OF THE WIRE APPROXIMATELY 4-5 CM OF THE DISTAL PART. THIS WAS CURRENTLY LOCATED IN THE MIDDLE CEREBRAL ARTERY. A RETRIEVAL OF THE FRACTURED GUIDEWIRE THROUGH A LOOP AND IT WAS COMPLETELY REMOVED WITHOUT COMPLICATIONS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 15933029 ↗MalfunctionDec 1, 2022Peeled/Delaminated; Peeled/Delaminated
ANALYSIS OF THE RETURNED DEVICE DISCOVERED THAT THE SUBJECT GUIDEWIRE PTFE (POLYTETRAFLUOROETHYLENE) AND HYDROPHILIC COATING PEELING. 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 15891875 ↗MalfunctionNov 29, 2022Peeled/Delaminated; Peeled/Delaminated
ANALYSIS OF THE RETURNED SUBJECT DEVICE FOUND THAT THE PTFE (POLYTETRAFLUOROETHYLENE) AND HYDROPHILIC COATING OF THE SUBJECT GUIDEWIRE WERE PEELED. 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 15875685 ↗MalfunctionNov 14, 2022Peeled/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 AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15787121 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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