Lutonix® Drug Coated Balloon LX35100640Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741088285), received between Jun 30, 2016 and Jun 30, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2016Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED, AFTER TREATMENT, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT A VESSEL DISSECTION. THE HEALTH CARE PROFESSIONAL (HCP) USED AN ANTEGRADE APPROACH WITH A COOK AMPLATZ 035 GUIDEWIRE TO GAIN PATIENT ACCESS. THE PATIENT WAS TREATED WITH TWO BALLOONS. BOTH LUTONIX DCB'S WERE USED, WITHOUT ISSUES, TO TREAT THE TARGET LESION. AFTER THE SECOND BALLOON WAS INFLATED, THE HCP NOTED A SMALL DISSECTION AND REINSERTED THE SECOND LUTONIX DCB TO POST DILATE THE DISSECTED REGION. THE POST DILATION WAS SUCCESSFUL. DURING THE REMOVAL OF THE DCB, AFTER THE TREATMENT OF THE DISSECTION, THE HCP EXPERIENCED DIFFICULTY REMOVING THE GUIDEWIRE. UPON REMOVAL OF THE GUIDEWIRE AND CATHETER, THE HCP NOTED KINKS IN THE GUIDEWIRE, WHICH MAY HAVE CONTRIBUTED TO THE REMOVAL DIFFICULTY. IT IS UNKNOWN IF NEGATIVE PRESSURE WAS APPLIED DURING CATHETER REMOVAL. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 5761682 ↗