Transend™ EX M001468080Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729326267), received between Aug 8, 2016 and Dec 7, 2022 — classified as 2 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
Device problems
- Break5
- Peeled/Delaminated4
- Fracture3
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient9
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
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 22, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE FOR A BA (BASILAR ARTERY) ANEURYSM CASE, PHYSICIAN USED THE FIRST 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 FIRST GUIDEWIRE TO THE TARGET POINT. DURING THE DELIVERY OF THE FIRST GUIDEWIRE, FRICTION WAS ENCOUNTERED, AND THE DISTAL TIP FRACTURED AT THE CONNECTION OF VA AND BA. PHYSICIAN WITHDREW THE FIRST GUIDEWIRE AND USED A MICROCATHETER TO REMOVE THE FRACTURED PART. THE PHYSICIAN PROCEEDED TO USE THE SECOND SUBJECT 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 11060789 ↗MalfunctionMay 29, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE GUIDEWIRE (SUBJECT DEVICE) WAS INSERTING INTO THE MICROCATHETER AND WAS BRIEFLY ADVANCING BEYOND THE TIP OF THE MICROCATHETER TO THE RIGHT M2 BRANCH; IT WAS THEN WITHDRAWN AND USED IN THE SUPRACLINOID INTERNAL CAROTID ARTERY (ICA). WHEN THE PHYSICIAN TRIED TO SELECT THE A1 ORIGIN, AT THIS POINT IT WAS NOTED THAT THE TIP (SUBJECT DEVICE) DID NOT APPEAR TO BE ROTATED IN RESPONSE TO THE MOVEMENT OF THE TORQUE DEVICE AND THE TIP (SUBJECT DEVICE) WAS NOT ENGAGED IN A SMALL VESSEL. NO RESISTANCE WAS FELT. THE TORQUE DEVICE WAS TIGHTENED AND STILL NO MOVEMENT WAS SEEN. ANOTHER TORQUE DEVICE WAS USED, BUT THE SAME ISSUE OCCURRED. IT WAS REALIZED THAT WHEN WITHDRAWING THE WIRE (SUBJECT DEVICE), THE TIP (SUBJECT DEVICE) DID NOT MOVE AND IT WAS NOTED THAT THE WIRE (SUBJECT DEVICE) WAS DISCONNECTED BETWEEN THE PLATINUM TIP AND THE REMAINDER OF THE WIRE. APPROXIMATELY HALF OF THE DETACHED TIP (SUBJECT DEVICE) WAS IN THE MICROCATHETER. A SNARE WAS CONSIDERED, BUT ASPIRATION ON THE MICROCATHETER WITH CAREFUL WITHDRAWAL WITH ASPIRATION OF ALL THE REMAINING COAXIAL CATHETERS (VIA 33, CATALYST AND NEUROMAX CATHETER) ALLOWED REMOVAL OF THE DETACHED TIP
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10101997 ↗MalfunctionMay 20, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT IT WAS BROKEN/FRACTURED INSIDE THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE ARE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10077071 ↗MalfunctionJul 1, 2019Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING PREPARATION, THE POLYTETRAFLUOROETHYLENE (PTFE) COATING OF THE SUBJECT GUIDEWIRE WAS OBSERVED TO BE PEELING. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8749144 ↗InjuryFeb 4, 2019Break; Break
IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE GUIDEWIRE BROKE OFF INSIDE PATIENT IN THE CAROTID ARTERY AND HAD TO BE RETRIEVED WITH A SNARE DEVICE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8303424 ↗MalfunctionNov 30, 2018Break; Break
IT WAS REPORTED THAT THE GUIDEWIRE HAD BROKEN DURING USE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8120973 ↗MalfunctionOct 10, 2018Peeled/Delaminated; Peeled/Delaminated
DURING ANALYSIS OF THE RETURNED PRODUCT, OT WAS FOUND THAT THE GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) WAS PEELED/SCRAPED OFF. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7954606 ↗MalfunctionJul 21, 2018Break; Break
ANALYSIS OF THE RETURNED GUIDEWIRE FOUND IT WAS BROKEN AT THE DISTAL END. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7708743 ↗MalfunctionJan 24, 2017Break; Break
DURING THE PROCEDURE UPON INSERTION OF THE WIRE INTO THE MICROCATHETER, THE GUIDEWIRE BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6274913 ↗MalfunctionNov 30, 2016Peeled/Delaminated; Peeled/Delaminated
DURING THE GUIDEWIRE PREPARATION, A PIECE OF DEBRIS WAS NOTED ON THE TORQUE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6136830 ↗MalfunctionAug 30, 2016Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT WHILE THE GUIDEWIRE WAS PUSHED THROUGH THE MICROCATHETER, THE HYDROPHILIC COATING WAS PEELED OFF .THERE WERE NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5913903 ↗MalfunctionAug 8, 2016Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE THE GUIDEWIRE BROKE OUTSIDE THE PATIENT. NO CONSEQUENCES TO THE PATIENT WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5853949 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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