Transend™ M001468130Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729326304), received between Sep 30, 2021 and Feb 26, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 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 DURING THE PROCEDURE, THE DEVICE BECAME STUCK WITHIN A NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER AND COULD NOT BE WITHDRAWN.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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. AN 18X165 CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE. DURING INSERTION, THE CONNECTION BETWEEN THE HAND-HELD END OF THE MICRO GUIDEWIRE AND THE MAIN BODY OF THE GUIDEWIRE WAS FRACTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16029462 ↗
• MalfunctionSep 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. AN 18 165CM MODEL TRANSCEND GUIDEWIRE WAS UNPACKED AND OPENED, HOWEVER, IT WAS NOTED THAT IT WAS DETACHED IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12553656 ↗