MAUDE report

MAUDE report 17474: INTRA-AORTIC BALLOON CATHETER

Injury · received Sep 1, 1994 · ARIES-ST. JUDE MEDICAL

Key facts

MDR report key 17474
Report number 17474
Event type Injury
Brand name INTRA-AORTIC BALLOON CATHETER
Model number UNKNOWN
Catalog number UNKNOWN
Manufacturer ARIES-ST. JUDE MEDICAL
Product code DYG
Device class Class II
Date received by FDA Sep 1, 1994
Report date Mar 10, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 10–99 Death reports for this brand
  • 10–99 Injury reports for this brand
  • Yes 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:

Browse all MAUDE medical device reports