TransendRecalls & reported problems across all models

We found 6 models of Transend by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2019 and Aug 28, 2026 — classified as 6 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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

Most reported Transend problems

Transend models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Transend™ M001468100

  WIRE, GUIDE, CATHETER
  15 reports
• Transend™ M001468110

  WIRE, GUIDE, CATHETER
  13 reports
• Transend™ M001468010

  WIRE, GUIDE, CATHETER
  10 reports
• Transend™ M001468130

  WIRE, GUIDE, CATHETER
  8 reports
• Transend™ M003468020

  WIRE, GUIDE, CATHETER
  2 reports
• Transend™ M001468120

  WIRE, GUIDE, CATHETER
  2 reports

Recent Transend adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508432 ↗
• MalfunctionJul 22, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25906919 ↗
• MalfunctionFeb 26, 2026Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE STUCK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 165CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, ABNORMAL LUMEN DEFORMATION OCCURRED, CAUSING THE GUIDEWIRE TO BECOME STUCK. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456321 ↗
• MalfunctionFeb 26, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DEVICE REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE LIVER. A 150/20 RENEGADE HI FLO AND A .014/190 CM GW TRANSEND PERIPH WAS SELECTED FOR USE. DURING THE PROCEDURE, THE RENEGADE AND TRANSCEND DEVICES WERE UNABLE TO ADVANCE THROUGH A 5F GUIDE CATHETER AT THE PROXIMAL END, JUST BEYOND THE HUB. A NEW GUIDE WAS ATTEMPTED, BUT THE SAME ISSUE OCCURRED WITH THE FIRST RENEGADE AND TRANSCEND. NEW RENEGADE AND TRANSCEND DEVICES WERE THEN OPENED AND ADVANCES TO THE TIP OF THE 5F GUIDE, THE RENEGADE WOULD NOT ADVANCE OUT THE TIP OF THE GUIDE. IT WAS NOTED THAT THERE WERE GRITTINESS AND FRICTION DURING INSERTION AND REMOVAL. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456302 ↗
• MalfunctionFeb 16, 2026Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION, WHICH EXHIBITED 20% STENOSIS, WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL OF THE SPLEEN. AN 18 165CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE BECAME STUCK WITHIN A NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER AND COULD NOT BE WITHDRAWN. THE DEVICE WAS PULLED OUT DIRECTLY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345446 ↗
• MalfunctionDec 15, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18NOV2025. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO CROSS THE LESION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE LIVER. A 135CM TRANSEND GUIDEWIRE WAS SELECTED FOR TRANSARTERIAL CHEMOEMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE PTFE COATING WAS PEELED AT THE PROXIMAL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802269 ↗
• MalfunctionNov 12, 2025Nonstandard Device; Failure to Advance; Material Integrity Problem; Nonstandard Device; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT TIP DAMAGE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT HAND SHUNT VESSELS. A 165CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE IN A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO AN OCCLUDED LESION, BUT IT COULD NOT CROSS THROUGH THE LESION. THE DEVICE WAS REMOVED AND UPON VISUAL INSPECTION, THE TIP APPEARED WORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535052 ↗
• MalfunctionSep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BROKEN TIP OCCURRED. A 165CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026862 ↗
• MalfunctionDec 6, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20NOV2024. IT WAS REPORTED THAT THE TIP OF THE WIRE WAS ASYMMETRICAL, AND NOT STRAIGHT. A 165CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE. WHEN THE PACKAGE WAS OPENED, THE TIP WAS FOUND ASYMMETRICAL, AND NOT STRAIGHT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE PROXIMAL POLYMER JACKET WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866834 ↗
• MalfunctionOct 31, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE WAS BROKEN DURING THREADING. THIS 0.014/190CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE TO TREAT A SEVERELY TORTUOUS TARGET LESION. DURING THE PROCEDURE, THE GUIDEWIRE BROKE WHILE THREADING, BUT IT WAS SUCCESSFULLY RETRIEVED USING A SYRINGE TO CREATE NEGATIVE PRESSURE FOR REMOVAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, AND NO COMPLICATIONS WERE REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20583064 ↗
• MalfunctionOct 1, 2024Difficult to Remove; Material Deformation; Material Integrity Problem; Difficult to Remove; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT DIFFICULTY REMOVING THE GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY (IIA). AN 18 165CM TRANSEND GUIDEWIRE WAS SELECTED FOR ENDOVASCULAR ANEURYSM REPAIR PROCEDURE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE GOT STUCK AND WAS DAMAGED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAS NO STENOSIS. THE DEVICE WAS BENT/KINKED. THE TIP OF THE WIRE BROKE AND COULD NOT BE RESHAPED. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER. NO ADDITIONAL INTERVENTIONS WERE PERFORMED. FOR THE COIL STUCK, THE CATHETER WAS REMOVED, AND BOTH THE DELIVERY WIRE AND COIL WERE WITHDRAWN OUTSIDE THE BODY SO THE PROCEDURE COULD CONTINUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348523 ↗
• MalfunctionApr 1, 2024Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06-MAR-2024. IT WAS REPORTED THAT DIFFICULTY ADVANCING OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. AN 18 165CM GW TRANSEND PERIPH GUIDEWIRE WAS SELECTED FOR USE IN A TRANSARTERIAL CHEMOEMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE COULD NOT CROSS THE MICROCATHETER NORMALLY AND WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE COATING WAS PEELED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010946 ↗
• InjuryFeb 14, 2024Failure to Advance; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WIRE DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA THE ULNAR CUTANEOUS VEIN OF THE UPPER ARM. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RADIAL CUTANEOUS VEIN. A 135CM GW TRANSEND PERIPH GUIDEWIRE WAS SELECTED FOR USE IN A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, THE GUIDEWIRE WAS UNABLE TO CROSS THE LESION AND WHEN ATTEMPTED TO REMOVE, A DIFFICULTY WAS ENCOUNTERED. THE WIRE WAS DETACHED AT AROUND 5CM FROM THE TIP AND THE SEPARATED FRAGMENT WAS RETRIEVED WITH A SNARE. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707386 ↗
• MalfunctionJan 11, 2024Fracture; Fracture

  IT WAS REPORTED DURING THE PERCUTANEOUS ARTERIOVENOUS FISTULA EMBOLIZATION PROCEDURE WHEN THE PHYSICIAN WAS MANIPULATING THE SUBJECT GUIDEWIRE, THE TIP OF THE DEVICE FRACTURED. THE SUBJECT GUIDEWIRE AND TIP FRAGMENT WAS REMOVED FROM THE PATIENT. THE SUBJECT GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499043 ↗
• MalfunctionNov 16, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. A .014/190CM TRANSEND GUIDEWIRE WAS ADVANCED FOR TREATMENT. DURING THE TRANS-ARTERIAL CHEMOEMBOLIZATION PROCEDURE, IT WAS FOUND THAT THE COATING PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150304 ↗

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