FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
- Recall number
- Z-0889-2007
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
- Status
- Terminated
- Initiated
- 2007-04-11
- Posted
- 2007-06-05
- Terminated
- 2007-12-12
- Reason
- Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit
- Root cause
- Other
- Action
- Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.
- Quantity
- 15 kits
- Distribution
- Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad
- Lot, serial or model codes
- Batch/Lot Numbers: 8529320, 8568190, 9371965
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJE
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- 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