Cryolife Soft Tissues Recall

Guidant Heart Diffibulator Recall

Guidant Corp. announced it was issuing a recall on its implanted cardiac defibrillator on June 17, 2005. Affecting around 50,000 of the devices, the Guidant recall is linked to at least 45 failures of the device and the deaths of two patients.

Cryolife Soft Tissues Recall

FDA urges the recall of soft tissues developed by CryoLife.

Contact a Cryolife soft tissue recall lawyer today if you or a loved one has received an implant of these potentially harmful soft tissues and learn more about the side effects of the soft tissue. Click here to contact a soft tissue recall lawyer today.

Nearly 900,000 implants are collected from donor cadavers and shipped to hospitals for surgical use every year. One of the nation's leading supplier of human tissue used in implants, CryoLife Inc. was forced to destroy human soft tissue after the FDA found the company was using inadequate procedures and exposing patients to deadly fungal and bacterial infections as a result. The human soft tissue implant had not been properly handled and resulted in at least Cryolife soft tissue recall -contaminated transplant video 26 serious infections in the patients.

CryoLife is unable to redistribute the tissue until the company starts meeting federal standards. According to an FDA commissioner, the agency "tried to work with CryoLife and get them in compliance, but it just didn't work." The FDA was especially concerned with the soft tissue from a cadaver CryoLife sent out despite it being confirmed that harmful germs were present in tissue samples they had obtained from the same donor. The FDA allowed CryoLife's heart valves to remain, but inspectors are currently studying them due to the reported problems of infection that continue to be made. Unlike soft tissue, recalling heart valves will create more of an impact due to its lack of alternative options in some instances, especially with babies.

The CryoLife recall order was an unusually strong move, but according to the director of the division of case management in the FDA's Office of Compliance and Biologics Quality, Dr. Mary Markley, the agency found "significant violations from our regulations." CryoLife is the nation's largest supplier of heart valves obtained from human donors and processes 70% of the nation's heart valves and 90% of vascular tissue. Patients who have received CryoLife soft tissue or heart valve implants should consult their physicians and contact us for more information from a tissue implant attorney.

CryoLife Soft Tissue Recall

On August 14, 2002, the FDA ordered CryoLife to immediately recall distributed human tissue processed from October 3, 2001 to the present. When the FDA inspected CryoLife from March 25- April 12, 2002, the agency found "numerous, significant violations of FDA regulation." The FDA issued a warning letter to CryoLife June 17, 2002 due to the companies inadequate processing and testing methods, as well as the failure to implement any CDC recommendations to better ensure their human tissue was not contaminated. While the CDC was only believed to be investigating CryoLife's soft tissue implants and heart valves and the soft tissue recall was for CryoLife's products only, in July 2002, the FDA also issued a warning letter to another tissue bank AlloSource for the series of problems with their processing procedures.

CryoLife Investigation

As CryoLife was receiving reports from doctors, laboratories, and the CDC of infections occurring because of their soft tissue implants, CryoLife continued to tell the investors that there was no contamination. Although CryoLife has backed off of that statement since then, they had continued to claim there were no problems for months. Records show that CryoLife key corporate officers and directors stopped buying and started to sell millions of dollars worth of stock when health investigators were sending the company letters. The SEC is now investigating this matter and shareholder are suing CryoLife, in addition to the families of the infection victims and the infected.
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If you or a loved one has received an implant of these potentially harmful soft tissues, please contact a lawyer today to learn more about the side effects of the soft tissue. Click here to contact a soft tissue recall lawyer today.

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