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Recall — Firm Press Release FDA posts press releases and other notices of recalls and mar

Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other inter­ested parties. FDA does not endorse either the product or the company.

Thoratec Corpo­ration Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System
Contact: Thoratec Corpo­ration 1–800-528‑2577

FOR IMMEDIATE RELEASEPLEASANTON, CA — October 24, 2008—Thoratec Corpo­ration is initi­ating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percu­ta­neous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoper­ation to replace the pump and poten­tially result in serious injury or death. The estimated proba­bility of the need for pump replacement due to percu­ta­neous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.

Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percu­ta­neous lead as well as provide proper instruction on management and care of the lead.

Thoratec is volun­tarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percu­ta­neous lead neces­si­tated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postop­er­a­tively. In five cases, pump replacement was not feasible and the patients expired.

The affected systems were distributed to 153 hospitals and distrib­utors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.

Hospitals are being sent an Urgent Medical Device Correction letter identi­fying the proba­bility and symptoms of the problem, and recom­mending that the pump be replaced as soon as possible if damage to the percu­ta­neous lead is confirmed. Hospitals are also requested to review the instruc­tions for care of the percu­ta­neous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instruc­tions if they do not receive the Medical Device Correction letter. The labeling for the HeartMate II LVAS will be revised with the updated risk infor­mation related to percu­ta­neous lead damage. Copies of this press release may be found on Thoratec’s website, www.thoratec.com, under Investor Relations/Press Releases.

Clini­cians and patients with questions may contact the company at 1–800-528‑2577, or if calling from outside the USA, 1–925-847‑8600 (7 days a week, 8–5 Pacific Time).

FDA has been informed of this action.