Skip to content

MAXI LD 4171640LRecalls & reported problems

Cordis Corporation · MAXI LD 7F 16X4 110CM · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032002551), received between Nov 13, 2018 and Nov 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Burst Container or Vessel1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionNov 13, 2018Burst Container or Vessel; Burst Container or Vessel

    DURING POST DILATION, IT WAS REPORTED THAT FOUR MAXI LD BALLOON CATHETER'S RUPTURE WITHIN THE STENT WHILE INFLATING WITHIN THE WALL STENT. THERE WAS NO PATIENT INJURY. THE USER FELT THAT THE BALLOONS WEREN'T WRAPPED AS WELL AS THEY USUALLY ARE AFTER THEY WERE REMOVED FROM THE PACKAGE. THIS ACCOUNT USES THESE BALLOONS FREQUENTLY AND IS VERY FAMILIAR WITH THE DEVICES. THE USER DOES NOT FEEL THAT THE BALLOON GOT CAUGHT ON A STENT STRUT WITHIN THE STENT AND RUPTURED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8066733 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

All Catheter, angioplasty, peripheral, transluminal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.