# K082034: Modification to Merci Retriever

- Pathway: 510(k) (Special)
- Applicant: Concentric Medical, Inc.
- Decided: Aug 15, 2008 after 29 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K071172 (2007). 2 ancestors in all.
24 later devices descend from it; 2 cite it directly.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081305: Merci Retriever, Concentric Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K090085: Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 (2009), 23 descendants of its own
- K113455: Solitaire FR Revascularization Device (2012), 22 descendants of its own
- K123378: Solitaire 2 Revascularization Device (2012), 18 descendants of its own
- K141491: Solitaire 2 Revascularization Device (2014), 17 descendants of its own
- K153071: Solitaire Platinum Revascularization Device (2015), 10 descendants of its own

## Recalls of this device
- Jun 25, 2014 · Class II · Z-2598-2014: Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.

## Indications for use
The Merci® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IVt-PA) or who fail IVt-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.

Source page: https://510kreport.com/device/K082034
Methodology: https://510kreport.com/methodology