K190527

Unknown

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters

Applicant: C. R. Bard
Product code: MSD
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-04
Decision date: 2020-03-05
Decision: Unknown
Clearance type: Traditional
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.