Z-0663-03

Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K

Name: Z-0663-03 Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K
Creator: Curon Medical Inc
Published: 2003-02-21
License: https://open.fda.gov/license/

Curon Medical, Inc. / initiated 2003-02-21 / Terminated

FDA source

Curon Medical Inc began a recall of Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K on 2003-02-21. The reason FDA records is "Catheter shaft has potential to crack during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0663-03
Status: Terminated
Initiated: 2003-02-21
Posted: 2003-03-20
Terminated: 2003-04-21
Recalling firm: Curon Medical, Inc.
Product: Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Catheter shaft has potential to crack during use.
FDA 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.
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.
Product codes and lots: FD1268 thru FD1282

Product code DQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)