AED Class I recall
This article was originally published in The Gray Sheet
Executive Summary
Welch Allyn's MRL division alerts customers June 14 that AED20 automated external defibrillators manufactured from April 2003 through October 2003 may fail to deliver appropriate therapy. Firm cites problems with an "electrical connection." The AED20 was the subject of another Class I recall in May 2005. Researchers highlighted concerns about AED recalls at Heart Rhythm Society Annual Meeting last month (1"The Gray Sheet" May 22, 2006, p. 12)...
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Another Class I AED recall
Welch Allyn's Aug. 24 recall of AED 20 automatic external defibrillators is Class I, the most serious designation, FDA says. Some 1,722 devices manufactured between October 2003 and January 2005 at a facility in Buffalo Grove, Ill., display an error message from an "intermittent electrical connection" that could lead to device failure, the firm says. The action follows a string of recalls from Welch Allyn, including Class I recalls for the AED 20 in June 2006 and May 2005 (1"The Gray Sheet" June 19, 2006, In Brief)
Welch Allyn expands AED recall
Firm's MRL division warns customers July 5 that PIC 50 automated external defibrillators manufactured from March 2002 through October 2004 may fail to deliver a shock due to an electrical contact problem. The Class I follows on the heels of a recall for Welch Allyn's AED20 automated external defibrillators, which have been the subject of two Class I recalls since May 2005 (1"The Gray Sheet" June 19, 2006, In Brief)...
Heart Rhythm Society Annual Meeting In Brief
ICD replacement woes?: Mayo Clinic physicians identified nine complications that resulted from 732 implantable cardioverter defibrillator replacement procedures performed at the clinic from 2000 through 2005 in research reported at the Heart Rhythm Society annual meeting May 18 in Boston. The group found that 162 of the replacements were due to recalls and advisories; 570 were elective procedures performed due to expected battery depletions. However, research recently published in the Journal of the American Medical Association and presented at the HRS meeting reported a notably higher complication rate. That study found 43 complications, including 31 requiring re-operation, resulting from 533 ICD replacement procedures performed in 17 Canadian centers between October 2004 and October 2005 (1"The Gray Sheet" May 1, 2006, p. 4). University of Western Ontario Professor Paul Gould, lead author of the latter study, said the observed complication rate "was much higher than we anticipated" and should make physicians think twice before replacing an ICD. Meanwhile, data from a 96-patient survey presented at the meeting by Mount Sinai Medical Center physicians revealed no significant difference in emotional status and overall quality of life between patients with recalled heart devices and devices that had not been recalled...