FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.
- Recall number
- Z-1106-04
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.
- Status
- Terminated
- Initiated
- 2004-06-25
- Posted
- 2004-07-20
- Terminated
- 2004-08-23
- Reason
- Mislabeled as to size; 10FR are labeled as 8FR.
- Root cause
- Other
- Action
- The firm hand delivered the recall notification to the consignee hospital on 6/30/04. Product at the customer have been relabeled by the firm.
- Quantity
- not on file
- Distribution
- Missouri.
- Lot, serial or model codes
- Lots 6030323, exp. 01-Nov-06; 6348004, exp. 01-Mar-07 and 6313957, exp 01-Mar-07.
- 510(k) numbers
- ["K820867"]
- PMA numbers
- not on file
- Product code
- GBO
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- 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