FDA Medical Device Recalls (openFDA)
Boston Scientific Target: Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
- Recall number
- Z-0260-2008
- Recalling firm
- Boston Scientific Target
- Product
- Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
- Status
- Terminated
- Initiated
- 2007-07-11
- Posted
- 2007-11-24
- Terminated
- 2007-12-05
- Reason
- Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)
- Root cause
- Labeling mix-ups
- Action
- Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.
- Quantity
- 49 units
- Distribution
- Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
- Lot, serial or model codes
- LOT 9311878, Catalogue #10142, Material #M003101420, Expires 10-JAN-2010
- 510(k) numbers
- ["K980453"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 2939204
- Firm city
- Fremont
- 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