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Ethicon has initiated a recall of its Gynecare Thermachoice III thermal balloon ablation silicone catheter.
The “voluntary recall involves only the catheter component of the Gynecare Thermachoice system (U.S. product codes TC003 and TC013). It does not involve other components of the Gynecare Thermachoice III Uterine Balloon Therapy System (controller, umbilical cable, etc.),” according to a Dec. 7 email from a company sales representative that was obtained by Ob.Gyn. News.
The thermal balloon ablation device is intended to ablate the endometrial lining of the uterus in premenopausal women who have completed childbearing and who experience menorrhagia from benign causes.
Ethicon said in the email that it is removing the product from the market “because stability data does not substantiate the labeled two-year shelf life of the product subject to the recall. There is no significant safety issue with the device.”
The company is advising physicians who have used the Thermachoice catheter to “continue to follow their patients in the usual manner.”
Ethicon officials did not respond to a request for comment on the product recall.
Ethicon has initiated a recall of its Gynecare Thermachoice III thermal balloon ablation silicone catheter.
The “voluntary recall involves only the catheter component of the Gynecare Thermachoice system (U.S. product codes TC003 and TC013). It does not involve other components of the Gynecare Thermachoice III Uterine Balloon Therapy System (controller, umbilical cable, etc.),” according to a Dec. 7 email from a company sales representative that was obtained by Ob.Gyn. News.
The thermal balloon ablation device is intended to ablate the endometrial lining of the uterus in premenopausal women who have completed childbearing and who experience menorrhagia from benign causes.
Ethicon said in the email that it is removing the product from the market “because stability data does not substantiate the labeled two-year shelf life of the product subject to the recall. There is no significant safety issue with the device.”
The company is advising physicians who have used the Thermachoice catheter to “continue to follow their patients in the usual manner.”
Ethicon officials did not respond to a request for comment on the product recall.
Ethicon has initiated a recall of its Gynecare Thermachoice III thermal balloon ablation silicone catheter.
The “voluntary recall involves only the catheter component of the Gynecare Thermachoice system (U.S. product codes TC003 and TC013). It does not involve other components of the Gynecare Thermachoice III Uterine Balloon Therapy System (controller, umbilical cable, etc.),” according to a Dec. 7 email from a company sales representative that was obtained by Ob.Gyn. News.
The thermal balloon ablation device is intended to ablate the endometrial lining of the uterus in premenopausal women who have completed childbearing and who experience menorrhagia from benign causes.
Ethicon said in the email that it is removing the product from the market “because stability data does not substantiate the labeled two-year shelf life of the product subject to the recall. There is no significant safety issue with the device.”
The company is advising physicians who have used the Thermachoice catheter to “continue to follow their patients in the usual manner.”
Ethicon officials did not respond to a request for comment on the product recall.