FDA Enforcement
Class II
Terminated
Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Recall: Z-2598-2014
·
Reported September 17, 2014
Enforcement
- Recall Number
- Z-2598-2014
- Event ID
- 69119
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Concentric Medical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 17, 2014
- Initiation Date
- June 25, 2014
- Classification Date
- September 8, 2014
- Termination Date
- October 29, 2014
- Address
- 301 E Evelyn Ave, N/A, Mountain View, CA, 94041-1530, United States
Description
Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Reason
Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
Code Info
Model Number 90109; Lot number 35695
Distribution
US Distribution including the states of PA, CA, TX, NM, and OH.
Quantity
9 devices