LUTONIX® Drug Coated Balloon BSLX3513061505FRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741123900), received between Oct 18, 2017 and Oct 18, 2017 — classified as 1 injury.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VESSEL DISSECTION WAS ALLEGEDLY PRESENT AFTER THE RIGHT SUPERFICIAL FEMORAL ARTERY(SFA) WAS TREATED WITH THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS. THE HEALTH CARE PROFESSIONAL (HCP) PERFORMED AN ATHERECTOMY, WITH A JETSTREAM, ON A THIRD OF THE PATIENT'S HIGHLY CALCIFIED TARGET LESION IN THE RIGHT SFA. THE ATHERECTOMY WAS NOT PERFORMING TO THE PHYSICIAN SATISFACTION AND DECIDED TO DISCONTINUE THE ATHERECTOMY. THE HCP ELECTED TO TREAT THE HIGHLY CALCIFIED LESION WITH THE LUTONIX DCB WITHOUT ADDITIONAL LESION PREPARATION. ALLEGEDLY, AFTER LUTONIX DCB TREATMENT, A DISSECTION WAS PRESENT. THE HCP PLACED AN INNOVA STENT. THE LUTONIX DCB'S WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2017-00194 AND 3006513822-2017-00195.

  Patient problems: Intimal Dissection

  MAUDE report 6957275 ↗