Transend™ EX M001468050Recalls & 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
- 20
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729187332), received between Jul 20, 2016 and Mar 11, 2024 — classified as 2 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Fracture8
- Peeled/Delaminated5
- Unclear Information1
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions6
- Neurological Deficit/Dysfunction1
- No Information1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
- Stroke/CVA1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionJul 11, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING INTRACRANIAL ANEURYSM EMBOLIZATION IN A PATIENT, THE SUBJECT GUIDEWIRE BROKE INTO 2 PARTS. BALLOON WAS REMOVED WITH DISTAL PORTION OF FRACTURED SUBJECT GUIDEWIRE. THERE WAS A SURGICAL DELAY OF 5 MIN DUE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14983284 ↗MalfunctionJun 28, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING CATHETERIZATION OF THE MICROCATHETER, THE PHYSICIAN NOTICED IN THE HUB, DETACHMENT OF THE HYDROPHILIC COATING OF THE GUIDEWIRE (SUBJECT DEVICE), DARK AND THIN MATERIAL. 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 14842627 ↗MalfunctionJan 4, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT GUIDEWIRE WAS FRACTURED INSIDE THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13150376 ↗MalfunctionNov 24, 2020Fracture; Fracture
IT WAS REPORTED THAT THE SUBJECT DEVICE GUIDEWIRE WAS COMPLETELY DETACHED FROM THE REST OF THE WIRE WHILE LOADING INTO THE MICROCATHETER SYSTEM. THE DETACHED TIP WAS SAFELY REMOVED FROM THE PATIENT. THE PHYSICIAN REPLACED IT WITH A DIFFERENT WIRE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10898607 ↗MalfunctionSep 11, 2020Unclear Information; Unclear Information
THE SUBJECT GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS ON (B)(6) 2020 AND THE GUIDEWIRE WAS EXAMINED. BASED ON THE INVESTIGATION OF THE DEVICE, IT WAS REVEALED THAT THE GUIDEWIRE WAS BROKEN/FRACTURED AT 71CM FROM THE PROXIMAL END. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10525088 ↗MalfunctionJul 15, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE THE END OF THE SUBJECT GUIDEWIRE WAS SNAPPED. 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 10281005 ↗MalfunctionMay 11, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDEWIRE WAS BROKEN WHILE ADVANCING THE CATHETER. ALL THE BROKEN PARTS OF THE SUBJECT GUIDEWIRE WERE REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10045460 ↗MalfunctionMar 18, 2020Fracture; Fracture
THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE GUIDEWIRE WAS BROKEN/FRACTURED INSIDE THE PATIENT'S ANATOMY DURING EMBOLIZATION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9849841 ↗MalfunctionNov 22, 2019Fracture; Fracture
IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) BROKE INTO TWO PIECES. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Information
MAUDE report 9366003 ↗InjuryAug 22, 2019Break; Break
A MEDWATCH FORM (MW5088033) WAS RECEIVED WHICH REPORTED THAT A FOREIGN BODY WAS NOTED ON CHEST X-RAY AND RETROSPECTIVELY IDENTIFIED ON ABDOMINAL X-RAY AFTER THE PROCEDURE FOR PICC LINE EXCHANGE ALONG WITH REPLACEMENT OF PERITONEAL DIALYSIS CATHETER. THEREFORE, THE PATIENT UNDER WENT CARDIAC CATHERIZATION UNDER ANESTHESIA FOR REMOVAL OF THE FOREIGN BODY FROM HER LEFT PULMONARY ARTERY. ASSESSMENT OF THE FOREIGN BODY BY PATHOLOGY USING LIGHT MICROSCOPY SUGGESTS THAT THE FOREIGN BODY IS CONSISTENT IN SIZE AND COLOR WITH THE GUIDEWIRE (SUBJECT DEVICE) USED FOR PICC LINE EXCHANGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8923560 ↗MalfunctionMay 7, 2019Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DURING PROCEDURE, THE GUIDEWIRE (SUBJECT DEVICE) BROKE. A NEW DEVICE WAS USED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8587598 ↗MalfunctionNov 20, 2018Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE INSERTING THE SUBJECT GUIDEWIRE INTO THE NON-STRYKER MICROCATHETER THE PROXIMAL SECTION OF THE GUIDEWIRE BROKE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8093063 ↗MalfunctionAug 24, 2018Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT WHEN THE GUIDEWIRE WAS BEING PREPPED FOR THE PROCEDURE, THE HYDROPHILIC COATING WAS OBSERVED TO BE PEELING FROM THE TIP. THE PHYSICIAN REPLACED IT WITH A NEW GUIDEWIRE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7813925 ↗MalfunctionAug 20, 2018Break; Break
IT WAS REPORTED THE GUIDEWIRE BROKE IN HALF WHEN REMOVED FROM THE MICROCATHETER (COMPETITOR DEVICE). THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7799451 ↗MalfunctionJul 21, 2017Break; Break
DURING THE PROCEDURE, IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN ADVANCING THE GUIDEWIRE (SUBJECT DEVICE) FROM THE INTRODUCER SHEATH TO THE MICROCATHETER. THEREFORE THE GUIDEWIRE WAS RETRIEVED AND IT WAS FOUND THAT THE DISTAL SECTION OF THE GUIDEWIRE WAS DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CHANGING TO ANOTHER GUIDEWIRE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6730858 ↗MalfunctionDec 20, 2016Break; Peeled/Delaminated; Break; Peeled/Delaminated
ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE GUIDEWIRE WAS BROKEN AND THE GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELING. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6188901 ↗MalfunctionJul 25, 2016Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDEWIRE WAS ROTATED IN ORDER TO ADVANCE THE GUIDEWIRE INTO THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN REMOVED THE GUIDEWIRE FROM THE PATIENT AND OBSERVED THAT APPROXIMATELY 50 CM OF THE PROXIMAL SECTION OF THE GUIDEWIRE WAS BROKEN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP OF THE GUIDEWIRE WITH THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5820941 ↗InjuryJul 20, 2016Break; Break
IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF BASILAR ARTERY TIP (RUPTURED) ANEURYSM, THE SUBJECT GUIDEWIRE BECAME JAMMED AND BROKE WITHIN A NON-STRYKER BALLOON CATHETER. THE DISTAL HALF OF THE GUIDEWIRE WAS REMOVED WITH THE CATHETER. IT WAS ALSO REPORTED THAT SINCE THE ANEURYSM WAS WIDE NECK, A NON-STRYKER COIL MIGRATED TO THE LEFT POST COMMUNICATING ARTERY (PCA), P2/P3 SEGMENT AND OCCLUDED IT. THE PATIENT OUTCOME WAS LEFT OCCIPITAL INFARCT WITH NEUROLOGICAL DEFECTS. THE PATIENT WAS GIVEN ACETYLSALICYLIC ACID (ASA) DRUG POST PROCEDURE. PHYSICIAN ASSESSED THAT THE RELATIONSHIP OF THE EVENT TO THE SUBJECT DEVICE WAS RELATED.
Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA
MAUDE report 5809148 ↗
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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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