FDA Medical Device Recalls (openFDA)
Boston Scientific Target: Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538
- Recall number
- Z-0122-2008
- Recalling firm
- Boston Scientific Target
- Product
- Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538
- Status
- Terminated
- Initiated
- 2007-06-14
- Posted
- 2007-12-05
- Terminated
- 2007-12-21
- Reason
- Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.
- Root cause
- Process control
- Action
- Boston Scientific issued a letter to all consignees by mail on June 14, 2007, titled Urgent Medical Device Recall or Correction - Immediate Action Required. The letter describes that the expiration date is incorrect. Discontinue use of the product, segregate it, complete the Reply Verification Tracking Form and fax it to Boston Scientific. Call 888-272-1001 to obtain a Returned Goods Authorization (RGA) number.
- Quantity
- 40
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot Number: 9264947.
- 510(k) numbers
- ["K931584"]
- PMA numbers
- not on file
- Product code
- DQX
- 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