FDA Medical Device Recalls (openFDA)
Kensey Nash Corp: TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.
- Recall number
- Z-1305-06
- Recalling firm
- Kensey Nash Corp
- Product
- TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.
- Status
- Terminated
- Initiated
- 2006-04-06
- Posted
- 2006-07-28
- Terminated
- 2006-08-10
- Reason
- Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting
- Root cause
- Other
- Action
- The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.
- Quantity
- 69 kits
- Distribution
- The product was shipped to hospitals in Germany and Italy.
- Lot, serial or model codes
- Part number 61000-01. Lot number 48275 exp 1/07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NFA
- 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