FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801.
- Recall number
- Z-0847-04
- Recalling firm
- Boston Scientific Corporation
- Product
- Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801.
- Status
- Terminated
- Initiated
- 2004-03-29
- Posted
- 2004-07-20
- Terminated
- 2005-10-13
- Reason
- Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.
- Root cause
- Other
- Action
- Letters dated 3/29/04 with instruction to remove and return product.
- Quantity
- 72 units
- Distribution
- not on file
- Lot, serial or model codes
- 916252, 917973
- 510(k) numbers
- ["K991897"]
- 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