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

Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA

FDA Recall Z-2581-2010 · Posted 2010-09-27

Recalling FirmCardima Inc
Recall StatusTerminated
Product CodeOCL
Date Initiated2010-05-20
Date Terminated2011-03-23
Product Quantity28 units

Reason for Recall

Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.

Firm Action

Cardima issued a Product Recall Notification dated May 18, 2010 to customers, identifying the affected product, the sterility issue, and the actions to be taken by the customer. Custormers are to quarantine and return the affected product to the firm. The firm will replace returned product as soon as it becomes available. Cardima Customer Service can be contacted at 800 354-0102.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers in the states of CA, OH, MI, MO, AND WA, and the countries of Ireland and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060715MODIFICATION TO: CARDIMA ABLATION SYSTEMCardima, Inc. · 2006-05-15K022008CARDIMA ABLATION SYSTEMCardima, Inc. · 2003-01-29

Official Source

View FDA Recall →

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

↑