FDA Medical Device Recalls (openFDA)
Curon Medical Inc: Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K
- Recall number
- Z-0663-03
- Recalling firm
- Curon Medical Inc
- Product
- Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K
- Status
- Terminated
- Initiated
- 2003-02-21
- Posted
- 2003-03-20
- Terminated
- 2003-04-21
- Reason
- Catheter shaft has potential to crack during use.
- Root cause
- Other
- Action
- On 2/21/03 the firm initiated the recall and its notification was via letters to inform its consignees about the problem with its catheters. It requests immediate discontinuance of all product with certain lot numbers.
- Quantity
- not on file
- Distribution
- Product was released for distribution to 52 direct accounts nationwide including 1 VA Medical Center, Endoscopy Dept., 150 S. Huntington Ave., Boston, MA 02130, ATTN: Dr. Hiroshi Mashimo, ph#: 617-363-5640.
- Lot, serial or model codes
- FD1268 thru FD1282
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 3007729452
- Firm city
- Sunnyvale
- 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