FDA Medical Device Recalls (openFDA)
Kensey Nash Corp: ThromCat Thrombectomy Catheter System. Catalog number 63000-01
- Recall number
- Z-1115-2007
- Recalling firm
- Kensey Nash Corp
- Product
- ThromCat Thrombectomy Catheter System. Catalog number 63000-01
- Status
- Terminated
- Initiated
- 2007-05-21
- Posted
- 2007-07-23
- Terminated
- 2007-08-29
- Reason
- Defective component (power supply)
- Root cause
- Other
- Action
- New power supplies were sent directly to Sales Representatives who personally replaced the defective power supplies and returned them to Kensey Nash. A voice mail to all affected KNC Sales Representatives went out on 5/21/07 instructing them to contact the affected accounts immediately.
- Quantity
- 11 units
- Distribution
- Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX.
- Lot, serial or model codes
- Catalog number 63000-01, Lot number 57292 exp March 2008
- 510(k) numbers
- ["K060016"]
- PMA numbers
- not on file
- Product code
- MCW
- Firm FEI
- 1000307073
- Firm city
- Exton
- Firm state
- PA
- 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