Navigation Links
Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE(TM) Brand Heparin-Coated Thoracic Drainage Catheters Used for Autotransfusion During Cardiopulmonary Bypass Surgery

HUDSON, N.H., May 12 /PRNewswire/ -- Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE(TM) Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. The U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS. While Atrium's HYDRAGLIDE Catheters do not contain high levels of heparin, there still exists a potential exposure of OSCS to the patient.

Customers with affected lots are advised to immediately discontinue use of these devices and obtain replacement catheters from Atrium. Atrium will be working with our customers to replace the affected product as soon as possible. If a non-elective procedure requires use of this catheter, we recommend that you do not use the catheter with either a cell saver autotransfusion system or direct autotransfusion chest drainage collection system for cardiopulmonary bypass surgery.

Atrium has not received reports of any OSCS-related adverse events arising from any use of their Hydraglide Thoracic Catheters. This voluntary recall is being initiated as a precaution to minimize any future potential risk.

The above Customer Notification actions are being taken with the knowledge of the U.S. Food and Drug Administration. Physicians and hospital personnel with product related questions should call the company at 1-800-5-ATRIUM, Monday-Friday, 8:00 AM to 5:00 PM EST.

About Atrium

Atrium's vast expertise in medical device technologies for the treatment of cardiovascular disease, hernia and adhesion prevention has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, and soft tissue repair. Maintaining a commitment to the latest ISO13485 Quality Standards, state-of-the-art manufacturing and automation, cell biology and biomaterial discovery programs, Atrium continues to excel in those healthcare segments that require more advanced surgical intervention for improvements in patient outcome. For more information, call 800-370-7899 or visit

SOURCE Atrium Medical Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Statehouse Atrium to be Site for Childrens Dental Access Event - Ohio Legislators to Mingle With Children and Dentists for This Free Care Event!
2. QLT initiates phase II study of punctal plug drug delivery system for glaucoma & ocular hypertension
3. Vista Partners Initiates Coverage on Arana Therapeutics (ASX: AAH; AIM: AAHx)
4. MGH initiates phase I diabetes trial
5. Wasserman Morris Initiates Research Coverage on Crdentia
6. Labopharm Initiates Phase III Clinical Trial for Twice-Daily Formulation of Tramadol-Acetaminophen
7. Akela Pharma initiates its first abuse deterrent opioid Phase I clinical trial
8. AAP Initiates Public Relations Effort to Counter Bad Vaccine Publicity
9. China Holdings Announces Starwood Research Institute Initiates Research Coverage
10. Edwards Lifesciences Initiates Patent Infringement Litigation Against CoreValve in the U.S.
11. PreMD Initiates FDA Review Process and Provides Corporate Update
Post Your Comments:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
(Date:6/23/2016)... , June 23, 2016 Bracket , ... launch its next generation clinical outcomes platform, Bracket eCOA (SM) ... held on June 26 – 30, 2016 in ... first electronic Clinical Outcome Assessment product of its kind to ... #715. Bracket eCOA 6.0 is a flexible platform ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of Astellas ... Brasil as the company,s second affiliate in Latin America . ... ... of Astellas Farma Colombia ... ...
Breaking Medicine Technology: