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Teleport Microcatheter 220-13-1000URecalls & reported problems

OrbusNeich Medical (ShenZhen) Co., Ltd. · Caatheter, Percutaneous · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955943058), received between Mar 24, 2019 and Mar 21, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult to Remove1
  • Material Separation1
  • Material Split, Cut or Torn1

Patient problems

  • Foreign Body In Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 21, 2024Material Separation; Material Separation

    A HEAVILY CALCIFIED PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WERE THE TARGET TREATMENT AREA. A 7F GUIDE CATHETER AND NON-CSI OR ABBOTT GUIDE WIRE WERE ADVANCED, THEN SEVERAL TREK BALLOONS WERE ADVANCED AND INFLATED TO PRE DILATE THE VESSEL. SHOCKWAVE AND INTRAVASCULAR ULTRASOUND (IVUS) WERE THEN ATTEMPTED TO BE ADVANCED BUT WERE UNSUCCESSFUL DUE TO THE HEAVY CALCIFICATION OF THE VESSEL. THE TELEPORT MICROCATHETER WAS ADVANCED, AND A WIRE EXCHANGED WAS PERFORMED FOR THE VIPERWIRE ADVANCE GUIDE WIRE. THE TELEPORT WAS REMOVED AND AS THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING PREPARED TO BE ADVANCED ONTO THE VIPERWIRE, THE FLUOROSCOPE WAS CHECKED, AND A DARK SPOT WAS OBSERVED ON THE VIPERWIRE. THE TELEPORT WAS CHECKED, AND IT WAS DISCOVERED THE RADIOPAQUE TIP HAD FRACTURED AND WAS IN VIVO. A NON-CSI OR ABBOTT GUIDE WIRE AND A TRAPPER BALLOON WERE ADVANCED TO ATTEMPT TO SECURE THE TELEPORT TIP BUT WAS UNSUCCESSFUL. IT WAS THEN OBSERVED, WHEN THE VIPERWIRE WAS MOVED THE TELEPORT TIP MOVED WITH THE VIPERWIRE. THE TELEPORT TIP WAS STUCK ONTO THE VIPERWIRE AND THE TWO WERE REMOVED TOGETHER THROUGH THE GUIDE CATHETER. NO COMPONENT WAS LEFT IN THE PA

    Patient problems: Foreign Body In Patient

    MAUDE report 18949006 ↗
  • InjuryMar 24, 2019Difficult to Remove; Material Split, Cut or Torn

    THE TELEPORT MICROCATHETER WAS PLACED OVER AN EXTERNALIZED R350 WIRE AND MARRIED UP TO THE 150CM CORSAIR PRO CATHETER WHICH WAS IN THE RETROGRADE POSITION IN THE LAD SEPTALS AND CIRCUMFLEX CTO. THE TELEPORT AND CORSAIR CATHETERS BECAME LOCKED TOGETHER AND WERE UNABLE TO BE PULLED APART. THE HUB OF THE CORSAIR WAS CUT AND AN ATTEMPT WAS MADE TO REMOVE THE DEVICES VIA ANTEGRADE ACCESS. WHEN THE PHYSICIAN PULLED ON THE TELEPORT, THE CATHETER WOULD NOT WITHDRAW UNTIL THE USE OF EXCESSIVE FORCE. ALL DEVICES WERE REMOVED FROM THE PATIENT, THE VESSEL WAS RE-WIRED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. EXPOSED WIRE WAS NOTED ON THE TELEPORT AFTER REMOVAL. ALL DEVICES WERE REMOVED AND NO DEVICE REMAINED IN THE PATIENT. RETURN OF THE DEVICE IS ANTICIPATED

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8446666 ↗

Other Catheter, Percutaneous devices

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Sources and updates

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