LUTONIX® Drug Coated Balloon BSCLX351306120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741104992), received between Mar 22, 2017 and Oct 18, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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

Recent adverse event reports

The 2 most recent of 2 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 3006513822-2017-00193 AND 3006513822-2017-00195.

  Patient problems: Intimal Dissection

  MAUDE report 6957651 ↗
• MalfunctionMar 22, 2017Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 10 ATMOSPHERES (ATMS) WHILE TREATING THE TARGET LESION IN THE COMMON FEMORAL ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) GAINED PATIENT ACCESS THROUGH THE RADIAL ARTERY WITH A 6 FRENCH INTRODUCER SHEATH. THE HCP INFLATED THE LUTONIX DCB TO 10 ATMS AT WHICH TIME THE BALLOON REPORTEDLY BURST. THE HCP THEN RETRACTED THE CATHETER, BUT IT BECAME STUCK ON THE DISTAL END OF THE INTRODUCER SHEATH. THE HCP SUCCESSFULLY REMOVED THE LUTONIX DCB AND THE INTRODUCER SHEATH AS A SINGLE UNIT WHILE MAINTAINING PATIENT ACCESS WITH THE GUIDEWIRE. THE HCP PLACED A NEW SHEATH AND USED A NEW DRUG COATED BALLOON TO SUCCESSFULLY TREAT THE TARGET LESION. IT IS UNKNOWN IF THE LESION AND PATHWAY/VESSEL MORPHOLOGY WAS CALCIFIED OR TORTUOUS. IT IS ALSO UNKNOWN IF THE HCP APPLIED NEGATIVE PRESSURE TO THE BALLOON DURING ADVANCEMENT. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6424945 ↗