FDA Medical Device Recalls (openFDA)
Possis Medical, Inc: AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 USA.
- Recall number
- Z-0469-06
- Recalling firm
- Possis Medical, Inc
- Product
- AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 USA.
- Status
- Terminated
- Initiated
- 2005-12-12
- Posted
- 2006-02-04
- Terminated
- 2006-11-08
- Reason
- It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.
- Root cause
- Other
- Action
- An Advisory Notice was emailed to OUS Distributors 12/12/2005. The Advisory identifies the product, reason for recall and action Distributor should take. Distributors are to notify their customer who received the affected lot and return it to the Distributor. The Distributor is to open the outer box and inspect the catheter inside the sterile tray. Mislabeled units are to be returned to Possis.
- Quantity
- 48
- Distribution
- Lot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands.
- Lot, serial or model codes
- model number: 105421-002, Lot number 56594
- 510(k) numbers
- ["K042874"]
- PMA numbers
- not on file
- Product code
- DXE
- Firm FEI
- 2183460
- Firm city
- Minneapolis
- Firm state
- MN
- 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