MAUDE report

MAUDE report 43120: CORDIS TITAN PTCA BALLOON

Malfunction · received Oct 18, 1996 · CORDIS CORP

Key facts

MDR report key 43120
Report number 1016427-1996-00039
Event type Malfunction
Brand name CORDIS TITAN PTCA BALLOON
Catalog number 536-0302
Manufacturer CORDIS CORP
Product code LOX
Device class Class II
Date received by FDA Oct 18, 1996
Report date Sep 12, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • No Adverse event flagged
  • Yes Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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