Bendit®21 Microcatheter BDT21157U2Recalls & reported problems
Bend It Technologies Ltd · The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 17290018072049), received between Nov 20, 2023 and Jul 16, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2024Break; Break
YOUNG FEMALE WITH A RIGHT SUPERIOR HYPOPHESEAL SEGMENT ANEURYSM. ACCESS VIA RADIAL APPROACH USING A RIST CATHETER. WHEN TRYING TO NAVIGATE THE ANEURYSM FROM CAVERNOUS TO SUP HYP, LACK OF RESPONSE ON ADVANCING OR PULLING BACK THE DEVICE WAS FELT. WHEN THE WHOLE SYSTEM WAS RETRIEVED, A FRACTURE WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19757149 ↗MalfunctionNov 21, 2023Break; Break
PATIENT WITH A GIANT CAVERNOUS SINUS ANEURYSM. RADIAL ACCESS WITH THE BENDIT21 MICROCATHETER WAS EMPLOYED TO REACH THE ANEURYSM. DURING THE ACCESS ATTEMPT, THE CATHETER BROKE AND WHILE REMOVING A DISTAL SECTION OF THE CATHETER REMAINED WITHIN THE FOREARM AND WAS REMOVED USING A SNARE. THE BENDIT21 MICROCATHETER IS INTENDED FOR FEMORAL ACCESS, THE RISK PROFILE OF USING THE DEVICE IN RADIAL ACCESS IS NOT KNOWN. THE PHYSICIAN TRANSFERRED TO FEMORAL ACCESS AND USED A SECOND BENDIT21 CATHETER WHICH SUCCEEDED TO OBTAIN ACCESS TO THE ANEURYSM AND ENABLE FURTHER TREATMENT OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18182213 ↗MalfunctionNov 20, 2023Break; Break
THE BENDIT21 MICROCATHETER WAS USED TO ACCESS THE ACA ANEURYSM ANEURYSM IN PATIENT WITH HIGHLY TORTUOUS BLOOD VESSEL ANATOMY. DUE TO THE EXTREMELY HIGH TORTUOSITY A SIGNIFICANT ARTICULATION AND TORQUING FORCES WERE APPLIED TO THE CATHETER RESULTING IN CATHETER BREAKAGE. CATHETER WAS REMOVED WITH NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18178687 ↗
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- CEREBASE GS9090SDCerenovus, Inc. · Catheter, Percutaneous, Neurovasculature1 recall2 deaths97 reports
- CEREBASE GS9095SDCerenovus, Inc. · Catheter, Percutaneous, Neurovasculature1 recall1 death33 reports
- CEREBASE GS9080SDCerenovus, Inc. · Catheter, Percutaneous, Neurovasculature1 recall13 reports
- Balloon Guide Catheter BOB-895-USMicrovention, Inc. · Catheter, Percutaneous, Neurovasculature1 recall11 reports
- 070 Access System Gen 1Route 92 Medical · Catheter, Percutaneous, Neurovasculature1 recall0 reports
- EMBOGUARD BG8785UNeuravi Limited · Catheter, Percutaneous, Neurovasculature1 death13 reports
- CEREGLIDE SBC92122UGCerenovus, Inc. · Catheter, Percutaneous, Neurovasculature9 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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