Boston Scientific Corp Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6649, inner pouch UPN M00566490 and outer carton UPN M00566491. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6649, inner pouch UPN M00566490 and outer carton UPN M00566491. 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.
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
M00566490, Lot Numbers: 18893672, 11942231 and 12163810, and M00566491, Lot Numbers: 11934737 and 11996717.
Products Sold
M00566490, Lot Numbers: 18893672, 11942231 and 12163810; and M00566491, Lot Numbers: 11934737 and 11996717.
Boston Scientific Corp is recalling Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine amp due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026