Thoratec initiates recall of heart device
Device Regulation Alert: Safety, Compliance and Reimbursement News, November 3, 2008
Thoratec issued a worldwide correction for some of its HeartMate II Left Ventricular Assist Systems, according to a press release.
Wear and fatigue to the percutaneous lead may result in damage that could interrupt pump function, require another operation to replace the pump, and potentially result in serious injury or death. Thoratec received 27 reports of wear leading to replacement of the device over five years of clinical experience with 1,972 implants.
The company recommends patients with the device ask their physicians to assess the amount of wear to the lead. Thoratic also sent a letter to hospitals identifying the probability and symptoms of the problem, and recommending the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed.
Comments
0 comments on “Thoratec initiates recall of heart device ”
Related Products
-
ePharm5 InDepth
EPharm5 e-mail newsletter delivers the top 5 developments in pharma business innovation, with original research, interviews...
-
Big Pharma Performance Before, During and Beyond the Global Recession
This report assesses the performance of the leading 15 pharmaceutical companies up to, during and beyond the recent global...
Most Popular
- Articles
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- Topic: CMS, OESS post new security compliance review information, checklist
- What does case-mix index mean to you?
- Capturing all necessary codes for IUD insertion and removal can be challenging
- QA:Coding multiple initial infusions
- News and briefs: Oklahoma Osteopathic Association against residency bill change
- OB services: Coding inside and outside of the package
- HIPAA Q&A: Level of encryption needed for email
- E-mailed
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- New conflicts of interest create new challenges
- Q&A tackles coding questions about injections and infusions
- Joint Commission Center announces handoff communication solutions
- Inside best practice: Reduce patient falls with a stoplight
- Identify modifiable risk factors to prevent patient falls
- Hospitalist-surgeon comanagement has no effect on outcomes
- Case Management Monthly, June 2012
- Searched