Contact Us

Lifesite Dialysis
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 

Phone 

Cell Phone 

Street Address 

Zip Code 

City 

State 

What medical condition prompted the use of the device?

Date Dialysis treatment started:

Is Dialysis treatment still underway?

If no, date Dialysis treatment ended:

Please describe any problems or injuries caused by the product:

Date adverse symptoms or injuries were noticed:

For verification purposes, please answer the below question:
+
=

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.


Vasca Responds to Filing of Lawsuit

Jun 26, 2002

Vasca, Inc., the developer, manufacturer and marketer of the LifeSite® Hemodialysis Access System, announced today that it has been named in a lawsuit filed in California on behalf of a LifeSite patient.

The suit asserts claims arising out of Vasca’s sale of the LifeSite System, including claims based on matters raised in an FDA Warning Letter issued to the company in November 2001.

The November 2001 Warning Letter includes issues on the complaint handling system and the timing of reported product complaints to the FDA. Many of these complaints were related to clinical issues seen with end stage renal disease patients and not to the LifeSite System.

Vasca has been working with the FDA, and the FDA has indicated that the company has taken appropriate corrective actions to address the concerns raised in the Warning Letter.

"We are continuing our review of this suit and will vigorously and confidently defend against the claims, particularly any allegation that questions the safety and efficacy of our product," said William "Mo" Cowan, counsel for Vasca.


Other articles
Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo