Enteer™ ENB-275-20-150Recalls & reported problems
Ev3, Inc · CATH ENB-275-20-150 CTO RE-ENTRY V03 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684073780), received between Sep 17, 2019 and Sep 17, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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.
Most reported problems
Device problems
- Burst Container or Vessel1
- Positioning Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2019Burst Container or Vessel; Positioning Problem; Burst Container or Vessel; Positioning Problem
PHYSICIAN INTENDED TO USE AN ENTEER RE-ENTRY BALLOON CATHETER WITH AN ENTEER GUIDEWIRE DURING TREATMENT OF A SEVERELY CALCIFIED VESSEL. THE DEVICES WERE UNSUCCESSFUL IN CROSSING. IT IS REPORTED DUE TO THE EXTREME CALCIFICATION THE BALLOON CATHETER BURST AND THE GUIDEWIRE TIP WAS DAMAGED. A SECOND ENTEER RE-ENTRY BALLOON CATHETER AND ENTEER GUIDEWIRE WAS THEN ATTEMPTED TO BE USED WITH THE SAME OUTCOME. THE PROCEDURE WAS ABORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9075214 ↗
Other Catheter for crossing total occlusions devices
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- Approach G50791Cook Incorporated · Catheter for crossing total occlusions2 recalls15 reports
- Approach G50792Cook Incorporated · Catheter for crossing total occlusions2 recalls7 reports
- Approach G50787Cook Incorporated · Catheter for crossing total occlusions2 recalls2 reports
- Approach G50786Cook Incorporated · Catheter for crossing total occlusions2 recalls1 report
- Approach G50788Cook Incorporated · Catheter for crossing total occlusions2 recalls1 report
- Approach G50789Cook Incorporated · Catheter for crossing total occlusions2 recalls0 reports
- OUTBACK OTB59120ACordis US Corp. · Catheter for crossing total occlusions82 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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