Transend™ M001468010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729326243), received between Oct 9, 2019 and Feb 26, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 15, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE APPROXIMATELY 15% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VISCERAL ARTERY. A 0.014/190CM TRANSEND GUIDEWIRE WAS SELECTED TO ADVANCE TO CROSS THE LESION. HOWEVER, DURING PROCEDURE, THE GUIDEWIRE ENCOUNTERED RESISTANCE AND DIFFICULT TO PULL OUT. THE DEVICE WAS REMOVED AFTER MULTIPLE ATTEMPTS TOGETHER WITH MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO INJURIES REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141472 ↗
• InjuryMay 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE DETACHED, REQUIRING THE PIECE TO BE SNARED. A TRANSEND GUIDEWIRE WAS SELECTED FOR USE IN A PROCEDURE. DURING THE PROCEDURE THE GUIDEWIRE BROKE IN THE PATIENT. THE PHYSICIAN WAS ABLE TO USE A SNARE TO REMOVE THE PIECE THAT WAS IN THE PATIENT. THE GUIDEWIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE TARGET LOCATION OF THE PROCEDURE WAS IN THE HEPATIC ARTERY. THE TRANSEND GUIDEWIRE WILL NOT BE RETURNED, AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991669 ↗
• InjuryMay 8, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MIDDLE CEREBRAL ARTERY. THE FIRST GUIDEWIRE WITH HYDROPHILIC COATING WAS USED FOR ACCESSING THE LESION BUT GUIDEWIRE FATIGUE OCCURRED. A .014/190CM TRANSEND GUIDEWIRE WAS ADVANCED DURING THE PROCEDURE; HOWEVER, THE GUIDEWIRE FRACTURED IN THE LESION AND COULD NOT BE RETRIEVED. THE PHYSICIAN USED ANOTHER GUIDEWIRE TO ACCESS THE OCCLUSION BUT FAILED DESPITE MULTIPLE ATTEMPTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16885954 ↗
• MalfunctionJan 5, 2022Fracture; Difficult to Advance; Fracture; Difficult to Advance

  IT WAS REPORTED THAT COATING PEELED OFF OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A .014/190CM GW TRANSEND PERIPH GUIDEWIRE WAS ADVANCED INSIDE THE PATIENT BUT RESISTANCE WAS FELT. UPON REMOVAL OF THE WIRE, IT WAS NOTICED THAT THE COATING OF THE WIRE HAD PEELED OFF; HOWEVER, NO COATING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173100 ↗
• MalfunctionJun 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A 0.014/190CM TRANSCEND GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, THE GUIDEWIRE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084824 ↗
• InjuryJun 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED BRONCHIAL ARTERY. A .014/190CM GW TRANSEND PERIPH GUIDEWIRE WAS ADVANCED INTO THE LESION; HOWEVER, DURING THE PROCEDURE, THE WIRE TIP WAS BROKEN. THE BROKEN WIRE TIP COULD NOT BE REMOVED DUE TO DIFFICULTIES IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12026328 ↗
• MalfunctionOct 9, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE GUIDEWIRE COATING WAS PEELING. A .014/190CM TRANSCEND GUIDEWIRE WAS USED IN A PROCEDURE. HOWEVER, WHEN THE DEVICE WAS PULLED OUT, IT WAS NOTED THAT THE HYDROPHILIC COATING WAS PEELING AWAY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9172213 ↗