FDA Medical Device Recalls (openFDA)
Kensey Nash Corp: ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.
- Recall number
- Z-0597-2007
- Recalling firm
- Kensey Nash Corp
- Product
- ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.
- Status
- Terminated
- Initiated
- 2007-02-07
- Posted
- 2007-03-08
- Terminated
- 2007-06-12
- Reason
- Face seal may wear excessively and cause particulate matter.
- Root cause
- Other
- Action
- On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product.
- Quantity
- 165 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot number 54877 exp December 2007, Lot number 55318 exp January 2008, Lot number 55218 exp January 2008, and Lot number 54821 exp December 2007
- 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