Transend™ 300 M003468150Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729441748), received between May 24, 2016 and Jun 29, 2026 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Fracture

  IT WAS REPORTED DURING THE RIGHT MCA M1 SEGMENT STENT RETRIEVAL PROCEDURE, THE PHYSICIAN FOUND IN-SITU STENOSIS AT THE MID-M1 SEGMENT. AFTER USING BALLOON FOR DILATION, A NON-STRYKER STENT WAS IMPLANTED. WHEN THE GUIDEWIRE WAS BEING REMOVED, THE TIP DID NOT FOLLOW WITH IT. THE TIP WAS BROKEN OFF AND REMAINED INSIDE THE VESSEL. DUE TO THE PATIENT BEING AGITATED, NO ATTEMPT WAS MADE TO REMOVE THE TIP FRAGMENT. UPON OBSERVATION, THE FRACTURED GUIDEWIRE TIP WAS STABLE IN THE VESSEL, AND BLOOD FLOW IN THE AFFECTED VESSEL WAS NOT COMPROMISED, SO THE PROCEDURE WAS CONCLUDED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651447 ↗
• MalfunctionMay 28, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE PHYSICIAN FOUND THE TIP OF THE SUBJECT GUIDEWIRE HAD COATING PEELING. ADDITIONAL INFORMATION RECEIVED CONFIRMED THERE WAS HYDRO PEELING TO THE SUBJECT GUIDEWIRE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323137 ↗
• MalfunctionSep 16, 2025Positioning Failure; Fracture; Peeled/Delaminated; Positioning Failure; Fracture; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A STENOSIS PROCEDURE, THE PHYSICIAN USED THE SUBJECT GUIDEWIRE TO ADVANCE THE BALLOON INTO POSITION. THE PHYSICIAN FOUND THAT THE BALLOON COULD NOT CONTINUE TO MOVE FORWARD WHEN IT REACHED A POINT 30 CM FROM THE SUBJECT GUIDEWIRE TIP, AND REPEATED ATTEMPTS YIELDED THE SAME RESULT. THEREFORE, THE BALLOON AND THE SUBJECT GUIDEWIRE WERE WITHDRAWN. AND UPON INSPECTION, IT WAS DISCOVERED THAT THE SUBJECT GUIDEWIRE COATING HAD WORN OFF AND GOT DETACHED AT A POINT OF 30 CM FROM THE SUBJECT GUIDEWIRE TIP. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064616 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A LEFT MIDDLE CEREBRAL ARTERY (MCA) STENOSIS CASE, SUBJECT GUIDEWIRE COULD NOT BE DELIVERED IN PROXIMAL OF MICROCATHETER. AFTER REMOVING IT OUT, SUBJECT GUIDEWIRE WAS FOUND FRACTURED. THE FRACTURED PART WAS REMOVED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031273 ↗
• MalfunctionJul 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PREPARATION THE OPERATOR FOUND ONE SMALL PART OF THE GUIDEWIRE (SUBJECT DEVICE) WAS SEPARATED FROM THE TIP OF THE GUIDEWIRE (SUBJECT DEVICE). THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE GUIDEWIRE (SUBJECT DEVICE) PTFE (POLYTETRAFLUOROETHYLENE) WAS NOTED TO BE PEELED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126854 ↗
• MalfunctionNov 1, 2021Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE PTFE (POLYTETRAFLUOROETHYLENE) COATING PEELING. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12734074 ↗
• MalfunctionSep 13, 2021Fracture; Fracture

  THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12461413 ↗
• MalfunctionAug 18, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE OPERATOR FOUND TIP OF GUIDEWIRE (SUBJECT DEVICE) DAMAGED WITHOUT HYDROPHILIC COATING. THE PROBLEM WAS NOTICED OUTSIDE PATIENT'S BODY AND NO PATIENT WAS IMPACTED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340312 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS STUCK INSIDE THE POSTERIOR COMMUNICATING ARTERY (PCA) WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE SUBJECT GUIDEWIRE. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO REMOVE THE SUBJECT GUIDEWIRE BUT WAS NOT SUCCESSFUL. THE PHYSICIAN HAD TO CUT THE SUBJECT GUIDEWIRE AT THE GROIN AND LEAVE IT BEHIND IN THE PATIENT'S ANATOMY. THE PHYSICIAN INDICATED THAT THE GUIDEWIRE WAS POSSIBLY ADVANCED INTO A SMALL PCA SIDE BRANCH RATHER THAN THE LARGER PARENT TRUNK AS EXPECTED. A SMALL VOLUME OF SUBARACHNOID HEMORRHAGE WAS NOTED IN PATIENT AROUND THE DISTAL END OF THE SUBJECT GUIDEWIRE POST PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS BEEN MADE PALLIATIVE.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11298368 ↗
• MalfunctionJan 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE(SUBJECT DEVICE) WAS ADVANCED WITH A BALLOON CATHETER TO LESION AT THE MCA (MIDDLE CEREBRAL ARTERY). ONCE THE POSITION WAS REACHED, THE GUIDEWIRE DISTAL TIP HAD FRACTURED AND THE FRACTURED PART WAS REMOVED FROM THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW GUIDEWIRE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9572161 ↗
• MalfunctionDec 13, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT GUIDEWIRE THROUGH THE MICROCATHETER SHAFT AND THE PHYSICIAN NOTED THAT THE GUIDEWIRE TIP COATING WAS MISSING AND UNEVEN. ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9470288 ↗
• InjuryJul 3, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT GUIDEWIRE WAS ADVANCED TO THE SITE TO PERFORM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND APPROXIMATELY ABOUT 3CM FROM THE TIP OF THE GUIDEWIRE WAS BROKEN. THE BROKEN PART OF THE GUIDEWIRE WAS REMOVED WITH A SNARE DEVICE. THE PATIENT¿S ANATOMY WAS REPORTED TO BE VERY TORTUOUS. THE PROCEDURE WAS STOPPED SINCE THE PHYSICIAN DID NOT HAVE ADDITIONAL GUIDEWIRE. THE PATIENT HAD EXPERIENCED A VISUAL FIELD DEFICIT ON THE RIGHT EYE THE DAY AFTER THE PROCEDURE. THE SYMPTOM WAS SLOWLY IMPROVED. THE PHYSICIAN THINK THAT THE CAUSE OF THIS EVENT WAS EMBOLUS OF RETINAL ARTERY BY EMBOLUS FROM THE RIGHT EYE ARTERY.

  Patient problems: Embolus; Visual Disturbances

  MAUDE report 8760781 ↗
• MalfunctionFeb 15, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE EXTREMITY OF THE GUIDEWIRE HAD PEELED OFF. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8344638 ↗
• MalfunctionSep 25, 2018Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING ON THE GUIDEWIRE WAS SCRAPED/ PEELING. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907733 ↗
• MalfunctionFeb 23, 2017Peeled/Delaminated; Peeled/Delaminated

  BASED ON INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE PTFE COATING WAS PEELED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6355208 ↗
• InjuryJan 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE TREATMENT OF THE 90% OF STENOSED LEFT INTERNAL CAROTID (IC) (C3- C4), THE STENT WAS DEPLOYED SUCCESSFULLY. POST PROCEDURE WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE FROM THE PATIENT, THE TIP OF THE SUBJECT GUIDEWIRE (ABOUT 3 CM FROM THE TIP) AND THE DISTAL EDGE OF THE STENT GOT STUCK. FOLLOWING SEVERAL ATTEMPTS TO REMOVE THE GUIDEWIRE USING DIFFERENT MICROCATHETERS, THE BALLOON CATHETER WAS INFLATED INSIDE THE STENT AND THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED WITH FORCE, BUT THE GUIDEWIRE WAS UNABLE TO BE REMOVED AND THE STENT MIGRATED TO THE IC-PETROUS PORTION. THEN THE STENT AND THE GUIDEWIRE WERE TRIED TO BE RETRACTED TO THE GUIDE CATHETER, BUT THE STENT WAS STUCK NEAR THE IC BIFURCATION. AN ATTEMPT TO RETRIEVE THE STENT USING A GOOSENECK SNARE FAILED AS WELL. THE STENT REMAINED IN THE PATIENT HOWEVER, THE GUIDEWIRE WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE CLINICAL CONSEQUENCES TO THE PATIENT A RESULT OF THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6221642 ↗
• MalfunctionMay 24, 2016Break; Break

  IT WAS REPORTED THAT DURING SHAPING OF THE GUIDEWIRE TIP, THE TIP BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5676496 ↗