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Latest Consumer News

• Class I Medical Device Recall: AngioScore Inc. - AngioSculpt "EX" PTCA Scoring Balloon Catheter - Reason for Recall: The PTCA catheters may become separated during use in which fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death.
• Class I Medical Device Recall: Ikaria Holdings, INOMAX DS Drug Delivery System - Reason for Recall: A component within the pressure switch, which monitors when the drug supply should be replaced, may tear. Risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a...
• Class I Medical Device Recall: Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls) - Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A "coring" Huber needle could damage the implanted port by removing silicone slivers from the access membrane...
• Class I Medical Device Recall: St. Jude Medical 6 French Engage? Introducer Devices - The Company identified that some devices in the affected batches have the potential for separation of the shaft (sheath) from the hub or for a break in the hub assembly. If either of these were to occur during use, a potentially life threatening...

Archive for November, 2008

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