FDA Medical Device Recalls (openFDA)
Spectranetics Corporation: Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
- Recall number
- Z-2190-2010
- Recalling firm
- Spectranetics Corporation
- Product
- Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
- Status
- Terminated
- Initiated
- 2010-07-01
- Posted
- 2010-08-09
- Terminated
- 2010-08-20
- Reason
- Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
- Root cause
- Process control
- Action
- Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978.
- Quantity
- 5080 units (1778 US, 3302 Non-US)
- Distribution
- Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela.
- Lot, serial or model codes
- Lot numbers FQT09K07A through FQT10F09A.
- 510(k) numbers
- ["K060092","K073519"]
- PMA numbers
- not on file
- Product code
- DXE
- Firm FEI
- 3007284006
- Firm city
- Colorado Springs
- Firm state
- CO
- 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