HeartWare Issued FDA Warning Letter
HeartWare has received a warning letter from the U.S. Food and Drug Administration concerning flagging inadequate procedures at the company’s plant in Miami Lakes, Florida.
HeartWare Flagged for Four Observances During Inspection
According to MassDevice, the FDA has asked HeartWare to address its procedures concerning:
- Validation of device design, including labeling.
- Corrective and preventive action
- Maintenance of records related to investigation
- Validation of computer software used as part of production or quality systems.
HeartWare has 15 days to respond to the FDA, and will be expected to present documents detailing proposed solutions of the observations.
FDA Issued Class 1 Recall on HeartWare Device in April
The warning letter comes just two months after the FDA issued a Class 1 recall for HeartWare’s Ventricular Assist System after the company received reports of driveline connector locking mechanisms failing to engage in the implantable devices due to a faulty manufacturing assembly process.
The company acknowledged that the problem could cause the pumps to stop working, potentially resulting in serious adverse health consequences and death.
Included in that recall were products manufactured from March 6, 2006 through October 17, 2013 and distributed from March 17, 2006 through November 29, 2013. The devices had the following catalog numbers and serial numbers:
- Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205
- Serial Numbers: HW001 to HW11270 and HW20001 to HW20296