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
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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