Guidant Device Recall

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Lawsuits for MRL AED20
MRL Welch Allyn Issues a Voluntary Worldwide Recall of Selected AED20 Automatic External Defibrillators

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The company has received 30 related complaints about devices in this group of AED20's, corresponding to 5 percent of the 580 recalled devices which the company deems an unacceptable risk. In one instance the "Defib Comm" error delayed patient resuscitation. The company has taken corrective action and no other devices besides those manufactured between the above dates are subject to this recall.

LAWSUITS - MRL AED20 Automatic External Defibrillators

 

FOR IMMEDIATE RELEASE -- Buffalo Grove, IL, June 15, 2006 -- MRL, Inc., a Welch Allyn Company, today announced it is initiating a voluntary worldwide Class I recall of 580 AED20 Automatic External Defibrillators manufactured in Buffalo Grove, IL between April and October of 2003, with serial numbers 205199 through 205786. These 580 AED20's may experience failure or unacceptable delay in analyzing the patient's ECG and may fail to deliver appropriate therapy, which possibly could result in failure to resuscitate the patient This will occur in combination with an error message on the device display reading "DEFIB COMM FAIL SELF TEST FAILED." This problem occurs because of an intermittent electrical connection within the device.

MRL, Inc initiated notification via certified mail on June 14, 2006 to its customers who purchased AED20's in this group of devices 369 of which were sold within the US and 211 outside of the US. Owners of this defibrillator should contact MRL, Inc. to obtain a loaner AED20 at no cost while their unit is being serviced. MRL, Inc. will pay all costs associated with shipping, handling and replacement of the units "DEFIB" board.

This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration (FDA). FDA has determined that this action is a Class I recall. The FDA defines Class I as a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

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What complications have you had from the Guidant defibrillator implant?


For What recommendations have your doctors made about removing this device?


For Please list any relevant Surgeons, Hospitals, and Cardiologists who are treating or have treated you with respect to the Guidant implant. (Please include city & state)



Implant Date: What was the date you
  received your implant?  

If removed, what was the date of
  REMOVAL of your implant?  

 

Which manufacturer's device has been implanted?
(please check all that apply)

   MRL (Welch Allyn)

   GUIDANT

   MEDTRONIC defibrillators

Which device(s) have been used? (see ID Card for Model #)
(please check all that apply)

   MRL AED20 Automatic External Defibrillator

   Ventak Prizm 2 DR (Model 1861), prior to April 16, 2002

   Contak Renewal (Model H135), prior to Aug. 26, 2004

   Contak Renewal 2 (Model H155), prior to Aug. 26, 2004

   Ventak Prizm AVT

   Vitality AVT

   Renewal 3 AVT

   Renewal 4 AVT

   Unknown or Other

Additional Guidant Recall Lawsuit Information:
Please be specific and tell us about your experience with the Guidant Defibrillator. Also enter any questions or comments in this space.


 

 
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