The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

Last week fallout continued resonate from the recall of
Baxter International’s heart surgery medication heparin, as popular medical
device maker, Medtronic, issued a recall for some disposable devices used during
heart surgery. The devices are coated with Medtronic’s Carmeda BioActive
surface that includes heparin. The company has not received any reports of
injury from the devices, but said that they issued the recall as a
precautionary measure.

 

The coating is used on blood oxygenators, reservoirs, pumps
and other disposable products that are used during the bypass surgery, the
company said.

 

At least 81 deaths have been linked to contaminated batches of heparin. These patients experienced classic signs of allergic reaction
including swelling of larynx and plummeting blood pressure among other
symptoms.

 

The FDA suspects that the contamination was a deliberate
attempt to pass off a similar but much cheaper product as raw heparin. The
contaminant, identified as chondroitin sulfate, is derived from animal cartilage and costs about 100 times less to
produce than heparin, which is extracted from pig intestines.

Baxter claims that
the contamination occurred somewhere in its Chinese supply line and was not
detected sooner because of the close similarity to of the contaminant to
heparin. Normal tests to ensure quality could not differentiate between
chondroitin sulfate and actual heparin.

Comments are closed.

Of Interest