Transend™ EX M001468070Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Boston Scientific Transend EX guidewire is a coated wire used to help place catheters. The 23 reports mostly describe the coating peeling off and the wire or tip breaking, sometimes with a fragment staying inside the catheter during removal. There were no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729326250), received between Jul 12, 2016 and Feb 23, 2024 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (11 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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated11
- Break10
- Fracture4
- Material Integrity Problem2
Patient problems
- No Consequences Or Impact To Patient12
- No Clinical Signs, Symptoms or Conditions10
- No Patient Involvement2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionApr 22, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE SUBJECT GUIDEWIRE WAS BROKEN WHILE ADVANCING THE MICROCATHETER OVER THE SUBJECT GUIDEWIRE. THE BROKEN FRAGMENT OF THE SUBJECT GUIDEWIRE WAS EXTENDED DISTALLY TO THE TIP OF THE MICROCATHETER. THE BROKEN FRAGMENT OF THE SUBJECT GUIDEWIRE AND THE MICROCATHETER WERE REMOVED TOGETHER OUT OF THE PATIENT'S ANATOMY. THERE WERE NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14190459 ↗MalfunctionJan 4, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT WHEN ADVANCING THE SUBJECT GUIDEWIRE THROUGH THE MICROCATHETER, IT WAS DELAMINATED DUE TO FRICTION. THE SUBJECT GUIDEWIRE GOT STUCK WITH CATHETER AND IT CAN NOT BE ADVANCED BUT CAN PULL BACK. THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13154824 ↗MalfunctionJul 22, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING A LIVER EMBOLIZATION PROCEDURE THE SUBJECT GUIDEWIRE TIP HAD FRACTURED OFF INSIDE THE MICROCATHETER. THE SUBJECT GUIDEWIRE TIP REMAINED WITHIN THE MICROCATHETER AND THE PHYSICIAN REMOVED THE MICROCATHETER AND GUIDEWIRE WITHOUT HARM TO THE PATIENT. PHYSICIAN REPLACED THE PRODUCTS WITH NEW DEVICES AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10311847 ↗MalfunctionJan 10, 2020Fracture; Fracture
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) TIP WAS BROKEN OFF WHILE INSERTING INTO CATHETER HUB. THE BROKEN TIP WAS REMOVED FROM THE CATHETER HUB. IT WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 9578672 ↗MalfunctionJun 21, 2019Break; Break
DURING ANEURYSM EMBOLIZATION, THE PHYSICIAN COULD NOT ADVANCE THE GUIDEWIRE (SUBJECT DEVICE) IN THE MICROCATHETER. THE GUIDEWIRE AND MICROCATHETER WERE REMOVED AND THE PHYSICIAN FOUND THE GUIDEWIRE HAD BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8725322 ↗MalfunctionJan 10, 2019Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE WHILE ADVANCING THE SUBJECT GUIDEWIRE THROUGH THE MICROCATHETER, RESISTANCE WAS FELT. WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE, A STRONG KINK WAS FELT AND IT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT WITHOUT ANY PROBLEM. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8238591 ↗MalfunctionNov 29, 2018Break; Peeled/Delaminated; Break; Peeled/Delaminated
ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT DEVICE WAS RECEIVED IN TWO FRAGMENT AND THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS SCRAPPED CLOSED TO THE FRACTURE SITE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8116118 ↗MalfunctionNov 15, 2018Break; Break
IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE GUIDEWIRE WAS FOUND TO BE BROKEN ON THE PROXIMAL SECTION WHEN REMOVED FROM THE DISPENSER HOOP. THE PHYSICIAN REPLACED IT WITH A NEW GUIDEWIRE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8075990 ↗MalfunctionOct 28, 2018Break; Break
IT WAS REPORTED THAT SUBJECT DEVICE WAS BROKEN UPON REMOVAL. THE BROKEN PART WAS REMOVED SAFELY FROM THE PATIENT BODY WITH THE MICROCATHETER AS ONE UNIT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8011369 ↗MalfunctionSep 26, 2018Break; Break
IT WAS REPORTED THAT THE MIDDLE OF THE SUBJECT DEVICE(GUIDEWIRE) WAS BROKEN WHEN DELIVERING IN THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7912829 ↗MalfunctionSep 17, 2018Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT GUIDEWIRE COULD NOT BE MANIPULATED. THE PHYSICIAN WITHDREW THE GUIDEWIRE FROM THE PATIENT'S BODY AND DURING INSPECTION, THE TIP OF THE GUIDEWIRE WAS BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 7881568 ↗MalfunctionAug 27, 2018Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE GUIDEWIRE BROKE DURING PREPARATION. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 7820636 ↗MalfunctionJul 10, 2018Break; Peeled/Delaminated; Break; Peeled/Delaminated
ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING ON THE GUIDEWIRE WAS SCRAPED/ PEELING AND THE GUIDEWIRE WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7676300 ↗MalfunctionMay 11, 2018Break; Peeled/Delaminated; Break; Peeled/Delaminated
ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE WAS BROKEN AND THE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS PEELED OFF. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7509100 ↗MalfunctionJun 16, 2017Peeled/Delaminated; Peeled/Delaminated
ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS SCRAPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6648628 ↗MalfunctionJan 10, 2017Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) PROXIMAL PART WAS FOUND BROKEN DURING UNPACKING. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6239406 ↗MalfunctionOct 24, 2016Peeled/Delaminated; Peeled/Delaminated
ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING ON THE GUIDEWIRE WAS SCRAPED/ PEELING. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6051903 ↗MalfunctionJul 12, 2016Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DISTAL TIP OF THE GUIDEWIRE (SUBJECT DEVICE) HAD SEPARATED WHEN ADVANCED INTO THE MICROCATHETER AGAINST FRICTIONS. THE GUIDEWIRE AND THE MICROCATHETER WERE RETRIEVED TOGETHER AS ONE UNIT WITHOUT ANY CLINICAL CONSEQUENCES FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5785308 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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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