J&J’s Cordis division is worried that one lot of its Fire Star Rx Balloon Catheters runs the risk of deflating too slowly or worse, not at all. The recall is limited to certain Far Eastern countries.
Product Recall
Outcome Data Drives S&N’s Metal Cup Recall
Smith & Nephew is withdrawing a component of one of its all-metal artificial hip systems following a higher than normal level of patient problems with the device. The fact that the recall was provoked by clinical outcome data points to the potential power of implant registries in regulating surgical implants.
Covidien’s Whispered Roticulator Recall
Covidien’s quietly recalling its Roticulators for packaging concerns, but seems to be doing so by stealth rather than adopting the slightly more communicative route one might expect to see.
Now FDA Issues Class I “Recall” For Thoratec Ventricular Assist Device
FDA draws attention to potential problems with Thoratec’s HeartMate II LVAS pump.
FDA Recall: Acclarent Inspira AIR™ Balloon Dilation System, Size 18X40mm
Acclarent’s voluntary recall of its Inspira Air™ balloon dilatation system has been formalised as a FDA Class 1 recall.
Cardiac Science Recalls Certain Automated External Defibrillators
Diligent QC inspections have identified a potential problem with some of Cardiac Science’s AEDs, prompting a recall.
Metal-on-Metal: Should FDA Concerns Have Made DePuy Act Sooner Overseas?
A new article in the New York times suggests J&J DePuy were wrong in continuing to sell product overseas after FDA raised concerns. If that happened every time FDA demanded more clinicals we might as well harmonise.
Covidien Updates Voluntary Recall of BIS™ Bilateral Sensors.
Covidien has reinforced implementation of its voluntary recall of BIS bilateral Sensors, undertaken last November, with a reminder in the form of an update, that use of affected iterations of the product could result in what the company refers to as inaccurate calucation and presentation of key data.
Covidien Contraindicates Use of Duet TRS™ For Thoracic Surgery And Implements Voluntary Recall.
Covidien has today announced that it is conducting a voluntary recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.
FDA Classifies Recent Urgent Device Correction on Baxter’s Colleague Infusion Pump as a Class I Recall
Baxter International Inc. announced today that the U.S. Food and Drug Administration has classified Baxter’s January 23, 2009 Urgent Device Correction letter to customers regarding U.S. COLLEAGUE® Volumetric Infusion Pumps as a Class I recall.