March 22, 2018 / 6:40 PM / 6 months ago

BRIEF-U.S. FDA Says Monteris Medical Is Recalling Its NeuroBlate Probe

March 22 (Reuters) -

* U.S. FDA SAYS PROVIDING PRELIMINARY INFORMATION ABOUT POTENTIAL FOR UNINTENDED HEATING, PATIENT INJURY WITH USE OF MONTERIS MEDICAL NEUROBLATE PROBE

* U.S. FDA - DEVICE IS CURRENTLY SUBJECT OF A VOLUNTARY RECALL WHICH WAS INITIATED BY THE FIRM, AND CLASSIFIED AS CLASS I BY THE FDA

* U.S. FDA - MONTERIS ISSUED THREE PRODUCT ADVISORIES BETWEEN OCTOBER AND DECEMBER 2017, WHICH WERE PART OF THE CLASS I RECALL

* U.S. FDA - HAS CONCERNS THAT INFORMATION PROVIDED BY MONTERIS HAS NOT SUFFICIENTLY MITIGATED RISK OF UNINTENDED PROBE TIP HEATING

* U.S. FDA - GOT MEDICAL DEVICE REPORTS RELATED TO OVERHEATING OF PROBE, INCLUDING 1 REPORT OF A PATIENT WHO EXPERIENCED INTRACRANIAL HEMORRHAGE & DIED

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