Note: There is a maximum of 200 words per comment. If you wish to post more, please visit our forum.
Heart device maker recalls implant
Monday, October 27, 2008 | No comments posted.
PLEASANTON, Calif. (AP) — A medical device company has ordered the recall of certain batches of a small mechanical heart pump, saying five people have died while using the device.
Thoratec Corp. urged patients to have their implants checked after confirming 27 reports of cases in which wear and fatigue to an electrical wire required the devices to be replaced, the company said in a statement Friday.
The reports occurred over five years of clinical experience with 1,972 implants, the company said. In five cases, the device could not be replaced and the patients died.
The recall affects devices with catalog numbers 1355 and 102139, which have been distributed to 153 hospitals and distributors throughout the United States and other countries since the beginning of clinical studies in November 2003.
A Thoratec spokeswoman did not immediately respond to a call seeking additional comment Sunday.
The HeartMate II pump was approved in April as a temporary treatment for patients awaiting heart transplants, but analysts had said the larger market for the product is in “destination therapy,” or patients with end-stage heart failure who are too ill for a transplant.
Thoratec Corp. urged patients to have their implants checked after confirming 27 reports of cases in which wear and fatigue to an electrical wire required the devices to be replaced, the company said in a statement Friday.
The reports occurred over five years of clinical experience with 1,972 implants, the company said. In five cases, the device could not be replaced and the patients died.
The recall affects devices with catalog numbers 1355 and 102139, which have been distributed to 153 hospitals and distributors throughout the United States and other countries since the beginning of clinical studies in November 2003.
A Thoratec spokeswoman did not immediately respond to a call seeking additional comment Sunday.
The HeartMate II pump was approved in April as a temporary treatment for patients awaiting heart transplants, but analysts had said the larger market for the product is in “destination therapy,” or patients with end-stage heart failure who are too ill for a transplant.
The comments below are from users of theworldlink.com and do not necessarily represent the views of The World or Lee Enterprises. Participation Guidelines
Note: There is a maximum of 200 words per comment. If you wish to post more, please visit our forum.
Note: There is a maximum of 200 words per comment. If you wish to post more, please visit our forum.
Not already registered?
The World welcomes your comments about stories, and we encourage a robust dialogue on this site. All comments must meet reasonable standards of decency and civility.
Please follow these basic rules:
- No defamatory comments about individuals or businesses.
- No deliberately false information.
- No obscenity or racially offensive language.
- No harassment, verbal abuse, threats or personal attacks.
- No information that invades another person's privacy.
- No business solicitations or charitable solicitations.
Comments that violate these standards will not be posted. Users with repeated violations may be banned from future posting.Comments will be approved throughout the day during business hours. After hours and weekend comments may not appear until the following business day. It may take a couple of hours before comments are approved.
The World generally does not edit comments, but we reserve the right to edit any comment that does not meet our standards.
Close Guidelines