1.5 mm OTW B-Laser™ catheter EXM-4001-0000Recalls & reported problems
Eximo Medical Ltd · 1.5 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290017590004), received between May 13, 2020 and May 13, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AT THE CLOSURE OF AN ATHERECTOMY PROCEDURE, IT WAS NOTED AN EXIMO 1.5 MM CATHETER BLADE HAD DETACHED WHILE INSIDE OF A PATIENT. ATTEMPTS TO REMOVE THE DETACHED BLADE FROM WITHIN THE PATIENT WERE UNSUCCESSFUL. THE BLADE WAS NOT REMOVED. THE PATIENT WAS REPORTED AS STABLE. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10052305 ↗
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- Turbo-Elite Laser Atherectomy Catheter 420-006Spectranetics Corporation · Catheter, Peripheral, Atherectomy2 recalls19 reports
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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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