On June 3, 2008, the FDA announced that there have been 11 deaths and 86 cases of harmful side effects since January 1, 2008 that have been linked to use of medical devices containing heparin. (See 06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.") The heparin in the majority of these medical devices was found to have the same contaminate, oversulfated chondroitin sulfate (OSCS), as found in Baxter heparin multiple-dose vials often used in dialysis and other medical procedures. Products coated with, containing or manufactured with heparin include:

In a media interview, the FDA said that these 11 deaths involving heparin medical devices are ``probably in addition'' to the 81 deaths stemming from Baxter heparin multiple-dose vials, though some of the reports to the FDA are ``very sketchy'' and there could be ``some minor overlap.'' (See 6/5/08 Blooomberg News, "Heparin in Medical Devices Linked to 11 U.S. Deaths.")

The majority of reports of death and injury from medical devices containing heparin were associated with use of heparin lock flush solutions in vials and solutions in pre-filled syringes, although reports have also been received for other medical devices listed above. (See 06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.")

This contamination can also lead to inaccurate test results from diagnostic diagnostic devices that monitor heparin or use it as part of the device itself. (See 06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.")

Heparin and medical devices containing heparin have been recalled by Baxter (01/25/08 Baxter recall notice and 02/28/08 Baxter recall notice), American Health Packaging (03/20/08 Am. Health Pkg recall notice), B. Braun (03/21/08 B. Braun recall notice), Covidien (03/28/08 Covidien recall notice), and Medtronic (05/14/08 Medtronic recall notice).