Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037

FDA Recall Z-0086-04 · Posted 2004-07-20

Recalling FirmConcentric Medical Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2003-09-24
Date Terminated2003-12-04

Reason for Recall

The device has the potential for tip breakage during use.

Firm Action

On 09/24/03, the firm issued letters and follow-up letters on 10/17/03 via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Root Cause

Other

Distribution Pattern

7 consignees in the US were shipped Concentric Retriever X5 or Concentric Retriever X6 devices with lot number 31494 or lower. A total of 97 units affected were released for US distribution. Distribution was limited to 6 States: MA, GA, NY, OH, MO and CA. The recall was appropriately extended to the user level; i.e., the hospitals which received the recalled products. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030476MODIFIED CONCENTRIC RETRIEVER, MODEL 90037Concentric Medical, Inc. · 2003-03-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑