Company voluntarily recalls IVADs
Device Regulation Alert: Safety, Compliance and Reimbursement News, November 26, 2007
Citing potential pneumatic leaks, Thoratec Corporation issued a worldwide voluntary recall of certain Implantable Ventricular Assist Devices (IVAD) made since October 2004 and bearing specific serial numbers. IVADs are pumps that help a patient's blood flow when the heart isn't strong enough to pump blood throughout the body.
In a November 8 press release, the company explained that when the device is positioned with the pneumatic driveline external to the patient's body, it could be damaged if that driveline is bent near the connection with the pump, potentially interrupting the device's support of blood flow. The recall is not directed at IVADs that are implanted internally.
The company issued an "Urgent Medical Device Correction" notice on October 19, 2007, with new instructions regarding placement of the devices. The company advised providers not to position IVADs with the driveline external to the body until it can determine if action is necessary to prevent the potential driveline problems. Patients who already have an externally positioned IVAD should contact their physician to determine if the driveline is at risk for bending.
Click here to read the FDA's notice. Click here to read Thoratec's press release.
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