FDA Medical Device Recalls (openFDA)
Cardima Inc: Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
- Recall number
- Z-2581-2010
- Recalling firm
- Cardima Inc
- Product
- Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
- Status
- Terminated
- Initiated
- 2010-05-20
- Posted
- 2010-09-27
- Terminated
- 2011-03-23
- Reason
- Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
- Root cause
- Device Design
- 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.
- Quantity
- 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 Netherlands.
- Lot, serial or model codes
- Model number 01-242208
- 510(k) numbers
- ["K022008","K060715"]
- PMA numbers
- not on file
- Product code
- OCL
- Firm FEI
- 1000150772
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28