FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394
- Recall number
- Z-1063-03
- Recalling firm
- Boston Scientific Corporation
- Product
- ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394
- Status
- Terminated
- Initiated
- 2003-07-03
- Posted
- 2003-07-29
- Terminated
- 2004-06-17
- Reason
- Sterility of the device may b e compromised due to a lack of package integrity
- Root cause
- Other
- Action
- Boston Scientific notified accounts by letter on 7/3/03. Accounts are requested to check inventory and return product. A Veification Form was requested to be completed.
- Quantity
- 2505 units
- Distribution
- Nationwide
- Lot, serial or model codes
- 4105648 4113988 4162641 4193798 4206664 4231542 4266299 4290089 4297846 4339339 4363204 4387477 4401411 4414613 4472494 4494612 4506626 4528577 4555320 4591333 4611363 4646473 4671080 4732694 4776718 4792615 4814439 4916050 4923749 4940371 4955250 5000456 5025458 5048339 5071211 5086862 5153158 5190439 5226638 5280768 5313310 5340135 5343856 5347420 5374497 5388620 5395693 5446265
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- 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