Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactur
FDA device recall Z-2580-2010 · posted 2010-09-27 · Terminated
Recall details
- Recalling firm
- Cardima Inc
- Reason for recall
- Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
- Action taken
- 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
- Status
- Terminated
- Product code
- OCL
- Quantity affected
- 28 units
- Distribution
- 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 Net
- Date initiated
- 2010-05-20
- Date posted
- 2010-09-27
- Date terminated
- 2011-03-23
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: CARDIMA ABLATION SYSTEM (K060715) | Cardima, Inc. | 2006-05-15 |
| CARDIMA ABLATION SYSTEM (K022008) | Cardima, Inc. | 2003-01-29 |