Description
FOR IMMEDIATE RELEASE -- MINNEAPOLIS – May
7, 2008 – Medtronic, Inc. today announced that
it is initiating a voluntary and precautionary recall of selected products
featuring the Carmeda BioActive surface. The affected devices are disposable
products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected
products include blood oxygenators, reservoirs, pumps, cannulae, and tubing
packs. This action is being taken subsequent to the U.S. Food and
Drug Administration's April 8, 2008 recommendation to device manufacturers
that heparin supplies be checked with newly-developed tests, and that affected
products be evaluated for possible field corrective action.
Limited lots of Carmeda-coated products were manufactured with heparin found
to have been contaminated with oversulfated chondroitin sulfate (OSCS). The
patient risk associated with the presence of OSCS in heparin-coated medical
devices is not known at this time. However, the U.S. Food and Drug Administration
has received reports of serious injury and death in patients who have been
administered injectable heparin products containing high levels of OSCS.
Medtronic has not received reports of any OSCS-related adverse events arising
from the use of Carmeda CPB products. It is unclear, however, if exposure
to Carmeda-coated medical devices, made with comparatively small amounts of
heparin, could cause adverse events similar to those observed with injectable
heparin formulations. As a result, Medtronic has initiated a precautionary
recall of affected Carmeda products.
In a separate action, Medtronic is advising customers that selected lots of
Trillium-coated products were also manufactured with heparin containing OSCS. Trillium
is another biosurface used on CPB products. The amount of heparin on
the product is significantly lower than that contained on the Carmeda product. Medtronic's
ultimate goal is to remove contaminated products from the market. However,
based on the current data, the benefit of using the affected products outweighs
any potential risk to patients. Since the maximum possible patient exposure
to heparin from Trillium is extremely low, customers can continue to use the
affected Trillium products until a replacement is available.
The above actions are being made with the knowledge of the U.S. Food and Drug
Administration. Patients with questions should talk to their physician. Physicians
or Pefusionists with medical questions related to Medtronic therapies should
contact Medtronic at 1-800-638 0218, Monday – Friday, 8:00 a.m.
to 5:00 p.m. CDT