FDA Medical Device Recalls (openFDA)
Spectranetics Corporation: Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
- Recall number
- Z-2952-2011
- Recalling firm
- Spectranetics Corporation
- Product
- Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
- Status
- Terminated
- Initiated
- 2011-07-18
- Posted
- 2011-08-04
- Terminated
- 2011-08-12
- Reason
- Packaging integrity may be compromised, thus sterility can not be assured.
- Root cause
- Package design/selection
- Action
- Spectranetics sent an "PRODUCT RECALL NOTICE: EU SHIPMENTS OF TURBO-BOOSTER LASER GUIDE CATHETERS" letter dated July 15, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and set aside affected product. Customers are to contact their sales representative for information on how to return the affected product and receive replacement product. Further information is available at +011.49.719.447.2539.
- Quantity
- 123 units
- Distribution
- Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom.
- Lot, serial or model codes
- Lot Numbers: CMP09L24C, CTB09G21A, FTB09M11A, FTB10C02A, FTB10F14A, FTB10H17B, FTB11D12A.
- 510(k) numbers
- ["K071226"]
- PMA numbers
- not on file
- Product code
- DQY
- 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