Medtronic Recalls Certain Disposables Made With Contaminated Heparin
This article was originally published in The Gray Sheet
Executive Summary
Safety concerns surrounding tainted lots of the anticoagulant drug heparin have moved more squarely into the device space with the "precautionary" recall of selected Medtronic products coated with the Carmeda BioActive surface
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Deaths linked to heparin-containing devices
FDA received reports of 11 deaths and 86 non-fatal adverse events associated with heparin-containing devices between Jan. 1 and May 14, 2008, according to a June 3 notice. The agency, which did not release the brands of the devices involved in the reports, says it has not determined conclusively that contaminated heparin caused the events. Most of the reports (82%) were associated with heparin lock flush solutions, such as the type Baxter recalled in January (Hep-Lock) due to heparin contamination. Other implicated devices include heparin-coated oxygenators and circuits used during bypass procedures and heparin-coated vascular grafts. Medtronic recalled heparin-coated cardiopulmonary bypass devices last month, but the firm had not received any adverse event reports for the products (1"The Gray Sheet" May 12, 2008, p. 3). The agency also notes that in vitro diagnostics tests that monitor heparin injected into patients or use tubes containing heparin to collect unclotted blood might also be impacted by the contamination, though no problems have been reported to date