Transend™ M001468100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729326274), received between Jan 9, 2019 and Dec 15, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJun 12, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE REMOVAL DIFFICULTIES AND COATING ISSUE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 135CM TRANSEND GUIDEWIRE WAS USED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, THE COATING ON THE EXTERNAL SHAFT PART OF THE GUIDEWIRE PEELED OFF AND THE WOLVERINE PERIPHRAL CUTTING BALLOON (PCB) BECAME STUCK. THE WOLVERINE PCB WAS REMOVED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A NEW TRANS-ENDO GUIDEWIRE AND WOLVERINE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107411 ↗
• MalfunctionFeb 6, 2023Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRODUCT PACKAGE SEAL WAS COMPROMISED. WHEN A 135CM MODEL-TRANSEND GUIDEWIRE WAS ARRIVED; IT WAS NOTED THAT THE BOX WAS FLATTENED, AND THE SEAL WAS PEELED OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303322 ↗
• MalfunctionSep 19, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING ISSUE WAS ENCOUNTERED. THE PATIENT PRESENTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 135CM TRANSEND GUIDEWIRE WAS ADVANCED FOR TREATMENT; HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE COATING CAME OFF. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447115 ↗
• InjuryDec 2, 2021Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT AND REMOVAL DIFFICULTIES OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED AT THE MODERATELY TORTUOUS AND MILDY CALCIFIED CEPHALIC VEIN. A 135CM TRANSEND GUIDEWIRE WAS TRIED TO CROSS THE LESION. THE GUIDEWIRE WAS TRIED TO BE INDUCTED INTO THE ARTERY SIDE OF THE ANASTOMOSIS SEVERAL TIMES, BUT THE DEVICE WAS UNABLE TO CROSS. SO THE GUIDEWIRE WAS TAKEN OUT FROM THE BODY ONCE AND THE SHAPE WAS ATTACHED INTO THE TIP. THE PHYSICIAN THEN TRIED TO CROSS THROUGH THE ANASTOMOSIS PART AGAIN, A BLACK OBJECT WAS CONFIRMED ON THE ELBOW PART THROUGH THE FLUOROSCOPY. THE GUIDEWIRE WAS REMOVED, AND THE TIP OF THE GUIDEWIRE WAS CHECKED, NO SEPARATION WAS OBSERVED. THEREFORE, ANOTHER NEW GUIDE WIRE WAS OPENED, AND WHEN THE TOTAL LENGTH WAS COMPARED, IT WAS CONFIRMED THAT THE ORIGINAL LENGTH OF THE TRANSEND GUIDEWIRE WAS ABOUT 1 CM SHORTER. DURING THIS TIME, A DETACHED GUIDEWIRE WAS CONFIRMED. THE ELBOW AREA WAS WRAPPED WITH CLEAN GAUZE TEMPORARILY IN PREPARATION FOR REMOVAL OF THE DETACHED GUIDEWIRE. WHEN IMAGING WAS PERFORMED WITH A SIMPLE COMPUTED TOMOGRAPHY (CT) REVEALED THE GUIDEWIRE WAS AROUND THE PAPILLARY MUSCLE NEAR THE RIGHT VENTRICLE. THE CAR

  Patient problems: Foreign Body In Patient

  MAUDE report 12917750 ↗
• MalfunctionApr 22, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WIRE PEELING OCCURRED. A 135CM TRANSEND GUIDE WIRE WAS SELECTED FOR USE FOR A TRANSARTERIAL CHEMOEMBOLIZATION PROCEDURE. DURING PREPARATION, THE DISTAL TIP COATING WAS FOUND PEELING WHEN IT WAS SHAPED 3 TO 4 TIMES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985887 ↗
• MalfunctionMar 20, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PEELING COATING OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 135CM TRANSCEND GUIDEWIRE WAS ADVANCED. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN TRIED TO MAKE THE SHAPE OF THE DISTAL TIP FOR 3-4 TIMES, AND NOTED PEELING COATING OF THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861071 ↗
• MalfunctionSep 23, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDE WIRE COATING WAS PEELED OFF. THE TARGET LESION WAS LOCATED IN THE LIVER ARTERY. A 135CM TRANSCEND GUIDE WIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, AS THE PHYSICIAN WAS MAKING THE SHAPE OF THE DISTAL TIP 3-4 TIMES, IT WAS NOTED THAT THE COATING OF THE DISTAL TIP WAS PEELING. 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 Consequences Or Impact To Patient

  MAUDE report 9105968 ↗
• MalfunctionAug 1, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT COATING WAS PEELED OFF. DURING A TRANSARTERIAL CHEMOEMBOLIZATION, A 135CM TRANSEND GUIDE WIRE WAS SELECTED FOR USE. HOWEVER, AFTER ONE USE, IT WAS NOTED THAT THE COATING WAS PEELED EASILY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851301 ↗
• MalfunctionJul 29, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 135CM TRANSCEND GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE OUTSIDE THE PATIENT, WHEN PHYSICIAN ATTEMPTED TO SHAPE THE DISTAL TIP 3-4 TIMES, IT WAS NOTICED THAT THE COATING OF THE DISTAL TIP PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8837150 ↗
• MalfunctionJul 24, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT COATING ISSUE WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 135CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE OUTSIDE THE PATIENT, WHEN PHYSICIAN ATTEMPTED TO SHAPE THE DISTAL TIP 3-4 TIMES, IT WAS NOTICED THAT THE COATING OF THE DISTAL TIP PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822625 ↗
• MalfunctionJul 10, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT GUIDEWIRE COATING PEELED OFF. THE TARGET LESION WAS LOCATED IN THE LIVER. A 135CM TRANSEND GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION, THE PHYSICIAN ATTEMPTED TO SHAPE THE DISTAL TIP 3-4 TIMES AND NOTED THAT THE COATING PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776145 ↗
• MalfunctionMar 26, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A FOREIGN OBJECT WAS PRESENT IN THE PACKAGE. A MODEL-TRANSEND 135CM LONG GUIDE CATHETER WILL BE USED FOR TREATMENT. WHEN UNPACKING THE DEVICE, AN INSECT OBJECT WAS OBSERVED INSIDE THE BOX. THIS DEVICE WAS NOT USED WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE FOREIGN OBJECTS WERE PLASTIC FRAGMENTS AND NOT THE INITIALLY REPORTED INSECTS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8453416 ↗
• InjuryJan 9, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE LESION WAS AT ANASTOMOSIS SITE OF CEPHALIC VEIN. THE LENGTH OF THE LESION IS APPROXIMATELY 1CM. THERE WAS NO CALCIFICATION. % OF STENOSIS IS UNKNOWN BUT IT WAS SEVERELY STENOSED. A 135CM MODEL-"TRANSEND" GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE GOT DETACHED AND HAD TO BE SURGICALLY REMOVED. SINCE THE DETACHED GUIDEWIRE TIP WAS SURGICALLY REMOVED THE SHUNT WAS NO LONGER ABLE TO BE USED. THE SHUNT WAS THEN RECONSTRUCTED AT SLIGHTLY CENTRAL SIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT SIZED DEVICE. THE CURRENT PATIENT CONDITION IS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8232664 ↗