GUIDANT CARDIAC SURGERY

Manufacturer adverse-event records for GUIDANT CARDIAC SURGERY come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2000–2009 · thin-book · quiet Death-code · balanced

Volume signature

GUIDANT CARDIAC SURGERY is a thinner MAUDE footprint

GUIDANT CARDIAC SURGERY accounts for 5,088 FDA MAUDE reports (#356 of 443, thin-book tercile). Death-coded event_type share is 0.04% (quiet); Injury share 12.9% (balanced).

What the volume reading shows for GUIDANT CARDIAC SURGERY

The standout signal for GUIDANT CARDIAC SURGERY is filing volume: 5,088 adverse-event reports in FDA MAUDE (#356 of 443, thin-book). Death-coded event_type share sits at 0.04% (quiet).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 9 device types, led in this extract by Malfunction at 4,406 (86.6% of event_type total). Peak single-year volume reaches 1,418 reports across 10 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,088
Total Reports
2
Event-type Death
655
Injury Reports
9
Device Types

Event Types

Malfunction 4,406 (86.6%)
Injury 655 (12.9%)
21 (0.4%)
Other 4 (0.1%)
Death 2 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

4,443 (87.1%)
Required Intervention 618 (12.1%)
Other 11 (0.2%)
R 9 (0.2%)
Life Threatening 7 (0.1%)
Congenital Anomaly 5 (0.1%)
Death 5 (0.1%)
O 1 (0.0%)
Hospitalization 1 (0.0%)

Yearly Trend

00
2000: 2
01
2001: 12
02
2002: 13
03
2003: 1,418
04
2004: 922
05
2005: 1,123
06
2006: 480
07
2007: 557
08
2008: 543
09
2009: 18