A Medical Device Daily
C. R. Bard (Murray Hill, New Jersey) said it is voluntarily recalling its Bard Composix Kugel Mesh X-Large Patch intended for ventral hernia repair. The recall does not affect any of the company's other hernia repair products.
The company is initiating this recall due to reports that the device's plastic coil ring, designed to aid in its deployment, may not withstand the increased stress associated with certain surgical placement techniques. The company has received 24 reports of broken rings out of some 32,000 units sold since 2002, a rate of about 0.08%.
The products affected by this recall were distributed to customers worldwide. Bard said it has notified affected customers and the appropriate regulatory agencies, including the FDA.
The three product codes involved generated sales of approximately $11 million in 2005, before the effect of the recall.
The company said it expects to record a sales reduction and related charges associated with the recall in 4Q05, and those adjustments will cause results to be below previously stated guidance for the quarter. Bard said it remains comfortable with its previously stated guidance for 2006 of constant currency net sales growth of between 9% and 10% and diluted earnings per share equivalent to a minimum of $3.42, excluding the effect of FAS123R.
In another recall action, Boston Scientific's (Natick, Massachusetts) Stainless Steel GreenfieldVena Cava Filters with 12 Fr femoral introducer systems manufactured before March 10, 2004, have been recalled as of Dec. 2.The product code for these devices is M001505010.
A vena cava filter is a small cone-shaped device implanted in the inferior vena cava, the large vein that carries blood from the lower part of the body to the heart. The filter prevents pulmonary embolism by capturing blood clots before they can be carried to the lungs. The blood clots are trapped in the filter while blood flows both through and around the entrapped clot, allowing the clot to dissolve naturally.
Boston Scientific said there have been reports of detachment at the bond between the carrier capsule and the outer sheath of the filter's delivery system during the implant procedure, putting patients at risk of cardiac and pulmonary embolization. Potential adverse events include serious patient injury or death.
Customers should return all unused devices with a “use before date“ prior to March 2007 to Boston Scientific.
The recall does not affect vena cava filters that have been implanted in patients.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.