MAUDE report

MAUDE report 46049: CORDIS TORQUE CONTROL BALLOON

Malfunction · received Oct 31, 1996 · CORDIS CORP.

Key facts

MDR report key 46049
Report number 9610978-1996-00017
Event type Malfunction
Brand name CORDIS TORQUE CONTROL BALLOON
Catalog number 530-712
Manufacturer CORDIS CORP.
Product code DQO
Device class Class II
Date received by FDA Oct 31, 1996
Report date Oct 31, 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
  • None 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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