MAUDE report

MAUDE report 28240: ROTABLATOR TYPE C GUIDE WIRE.009

No Answer Provided · received Jul 1, 1995 · HEART TECHNOLOGY, INC.

Key facts

MDR report key 28240
Report number 28240
Event type No Answer Provided
Brand name ROTABLATOR TYPE C GUIDE WIRE .009
Catalog number 22679-002
Manufacturer HEART TECHNOLOGY, INC.
Product code DQX
Device class Class II
Date received by FDA Jul 1, 1995
Report date Jun 30, 1995
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:

Browse all MAUDE medical device reports