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Concentric Medical Inc

Complete recall history across all FDA and CPSC categories — 5 total recalls

Concentric Medical Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (5)

FDA medical device enforcement actions by Concentric Medical Inc

Date Product Reason Class
Aug 19, 2015 Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF... One Distal Access Catheter intended for distribution in Korea, was found at a... Class II
Jun 25, 2014 Merci Retriever Intended to restore blood flow in the neurovasculature by ... Merci Retrievers were shipped to US customers past their expiration date, eve... Class II
Nov 13, 2013 Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: ... Product shipped to US customers had non U.S. Instruction for use with indicat... Class II
Sep 26, 2013 Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Di... Distal Access Catheters were shipped to US customers with the Directions for ... Class II
Dec 20, 2012 FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountai... Firm received complaints of resistance and possible collapse of the distal ti... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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