FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific EndoVive 24F (8 mm) Standard PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; inner pouch UPN M00568250 and outer carton UPN M00568251. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
- Recall number
- Z-1631-2009
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific EndoVive 24F (8 mm) Standard PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; inner pouch UPN M00568250 and outer carton UPN M00568251. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
- Status
- Terminated
- Initiated
- 2009-05-05
- Posted
- not on file
- Terminated
- 2010-10-13
- Reason
- The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- Root cause
- Process control
- Action
- Boston Scientific Corporation issued an "Urgent Medical Device Recall - Immediate Action Required" notice dated May 5, 2009 as follow-up to their "Recall of the Safety and Standard Push PEG Kits" dated December 30, 2008. The notice outlined the issue and Consignees were instructed to locate and return all affected product to the firm. In addition, the firm requests that users complete and return a Reply Verification Tracking Form via fax to 1-508-683-5578. For further questions, contact the Boston Scientific Corporation Field Action Team by phone at 1-508-683-4678.
- Quantity
- 238
- Distribution
- Worldwide Distribution -- United States, India, Japan and Slovenia.
- Lot, serial or model codes
- UPN M00568250 and UPN M00568251 Lot Numbers: 11942230, 11988701, 12043256, 12116837 and 12159829.
- 510(k) numbers
- ["K031538"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- 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