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FDA Mediation Watch: Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall – Complaints of Delivery System Tip Separation

By fdanews on Friday, May 24th, 2013 | No Comments

Inner delivery catheter breakage can lead to vascular occlusion, thrombosis, amputation, possible cardiac arrest, or death. MedWatch Safety Alert RSS Feed

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FDA Recall Alerts: Symbios Medical Products Issues Nationwide Recall of GOPump and GOBlock Kits

By fdanews on Monday, May 20th, 2013 | No Comments

May 10, 2013 – Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, [...]

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FDA Mediation Watch: Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall – Unit Goes Into Internal Backup Battery Sooner Than Expected

By fdanews on Thursday, May 2nd, 2013 | No Comments

The screen on the ventilator may indicate that the Power Pac battery is fully charged when it is not, or the unit may switch to backup battery power as soon as it is removed from AC power. MedWatch Safety Alert RSS Feed

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FDA Recall Alerts: Potential for Delivery System Catheter Separation Prompts Cook Medical to Initiate Voluntary Global Recall of Zilver® PTX® Drug Eluting Stent

By fdanews on Thursday, April 25th, 2013 | No Comments

Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent. Cook received 13 complaints of delivery system tip separation with an occurrence rate [...]

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FDA Mediation Watch: Medical Bed Mattresses: FDA Safety Communication – Damaged or Worn Covers Pose Risk of Contamination and Infection

By fdanews on Friday, April 19th, 2013 | No Comments

Damaged or worn covers can allow blood and body fluids to penetrate medical bed mattresses, posing a risk of infection to patients. MedWatch Safety Alert RSS Feed

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