Biocardia Recalls
3 recalls on record · February 26, 2014 to April 2, 2014 · Medical Devices
April 2, 2014Medical DevicesFDA
Biocardia, Inc. recalls Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Ca
Hazard: Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
April 2, 2014Medical DevicesFDA
Biocardia, Inc. recalls Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlo
Hazard: Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
February 26, 2014Medical DevicesFDA
Biocardia, Inc. recalls MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Steri
Hazard: Tyvek packaging may be worn, causing loss of package integrity.