FDA Medical Device Recalls (openFDA)
Concentric Medical Inc: Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037
- Recall number
- Z-0086-04
- Recalling firm
- Concentric Medical Inc
- Product
- Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037
- Status
- Terminated
- Initiated
- 2003-09-24
- Posted
- 2004-07-20
- Terminated
- 2003-12-04
- Reason
- The device has the potential for tip breakage during use.
- Root cause
- Other
- Action
- On 09/24/03, the firm issued letters and follow-up letters on 10/17/03 via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
- Quantity
- not on file
- Distribution
- 7 consignees in the US were shipped Concentric Retriever X5 or Concentric Retriever X6 devices with lot number 31494 or lower. A total of 97 units affected were released for US distribution. Distribution was limited to 6 States: MA, GA, NY, OH, MO and CA. The recall was appropriately extended to the user level; i.e., the hospitals which received the recalled products. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
- Lot, serial or model codes
- Lot numbers: 31494 or lower
- 510(k) numbers
- ["K030476"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3003271051
- Firm city
- Mountain View
- Firm state
- CA
- 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