Boston Scientific Corp Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. 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 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. 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
Inner pouch (UPN M00566470) lots 12004380, 12017735, 12039127, 12068485, 12074073, 1209443, 12115001, 12127100 and 12159831 Packaged in outer cartons (UPN M00566471) with lot numbers of 12069493, 12069494, 12112331, 12123598 and 12145424.
Products Sold
Inner pouch (UPN M00566470) lots 12004380, 12017735, 12039127, 12068485, 12074073, 1209443, 12115001, 12127100 and 12159831 Packaged in outer cartons (UPN M00566471) with lot numbers of 12069493, 12069494, 12112331, 12123598 and 12145424.
Boston Scientific Corp is recalling Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine a 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
Consignees were notified by "Urgent Medical Device Recall" letter dated 12/30/08. The letter described the problem with the product, instructed customers to determine whether they store these products in the outer carton or the inner pouch at their facility, to locate all affected products, and to return them to the firm. For additional information, contact Boston Scientific Corporation 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