Transend™ M001468110Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729326281), received between May 9, 2019 and Jul 22, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25906919 ↗
• 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 ↗
• MalfunctionJul 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE FRACTURED. DURING PREPARATION OF A 165CM TRANSEND GUIDEWIRE, A FRACTURE WAS FOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 17392622 ↗
• MalfunctionJul 19, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND NON-CALCIFIED UPPER ARM. A 165-CM MODEL-TRANSEND GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, DAMAGE OCCURRED, AND WHEN A GUIDEWIRE WAS ADVANCED TO A THROMBOTIC OCCLUSIVE LESION THE COATING ON THE TIP OF THE WIRE PEELED OFF. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352616 ↗
• MalfunctionMay 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THIS 165CM TRANSEND GUIDEWIRE WAS ADVANCED THOUGH MILD TORTUOSITY FOR TRANSCATHETER HEPATIC ARTERY DRUG-LADEN MICROSPHERE CHEMOEMBOLIZATION. HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE WAS BROKEN INTO TWO PIECES INSIDE THE MICRO CATHETER. THE MICROCATHETER AND THE GUIDEWIRE WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960978 ↗
• MalfunctionApr 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 165CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE TIP OF THE GUIDEWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709832 ↗
• MalfunctionJun 15, 2022Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20MAY2022. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE LIVER. A 165CM TRANSEND GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, BEFORE ENTERING THE PATIENT, THE GUIDEWIRE BECAME STUCK IN THE Y VALVE OF THE MICROCATHETER AND ONLY A PORTION OF THE GUIDEWIRE COULD BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL TIP POLYMER DETACHED AND COATING PEELED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14696635 ↗
• MalfunctionNov 1, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN SPLEEN. A 165CM MODEL TRANSEND GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE CATHETER WAS STUCK ON GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728991 ↗
• MalfunctionJul 29, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE PATIENT UNDERWENT TRANSARTERIAL CHEMOEMBOLIZATION (TACE). THE TARGET LESION WAS LOCATED IN THE LIVER. A 165CM TRANSEND GUIDEWIRE WAS USED TO CROSS THE LESION. HOWEVER, THE GUIDEWIRE WAS STUCK INSIDE THE CATHETER WHILE ADVANCING AND COULD NOT BE DELIVERED INTO THE PATIENT. THERE WAS ALSO DIFFICULTY REMOVING THE GUIDEWIRE FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247273 ↗
• MalfunctionAug 17, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY. A 165CM TRANSEND PERIPH GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING PROCEDURE THE PHYSICIAN NOTICED THAT THE COATING CAME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10416264 ↗
• MalfunctionJul 22, 2019Fracture; Difficult to Advance; Fracture; Difficult to Advance

  IT WAS REPORTED THAT GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A HEPATIC VESSEL. A165CM TRANSEND GUIDE WIRE WAS USED; HOWEVER, THE DEVICE FAILED TO PASS THROUGH THE CATHETER AND FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812768 ↗
• MalfunctionMay 14, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROSTATIC ARTERY. A 165CM TRANSEND GUIDE WIRE WAS SELECTED FOR USE FOR A PROSTATIC ARTERY EMBOLIZATION PROCEDURE. WHEN THE WIRE WAS BEING REMOVED FROM THE CATHETER, IT WAS RAN THROUGH A MOIST 4X4 TO WIPE IT CLEAN AFTER IT WAS ENTERED INTO THE PATIENT'S BODY. IT WAS THEN NOTICED THAT THE COATING ON THE WIRE WAS COMING OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8607971 ↗
• MalfunctionMay 9, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEPATIC ARTERY. A 165CM TRANSEND GUIDEWIRE WAS SELECTED FOR TRANSARTERIAL CHEMOEMBOLIZATION PROCEDURE. HOWEVER, THE WIRE FAILED TO MOVE FORWARD AND SO THE PHYSICIAN PULLED IT BACK. IT WAS FOUND THAT THE SURFACE OF THE WIRE WAS VERY HARSH AND THE COATING WAS ALMOST TAKEN OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT SERIOUS INJURY NOR COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595516 ↗