Device Recall Boston Scientific

M00566470, Lot Numbers: 11898070, 11900304, 11098441, 11915503, 11916278, 11922657, 11930346, 11952977, 12018370, 12143998 and 12149325; and M00566471, Lot Numbers: 11906398, 11931539, 11942414, 11946168, 11957022, 11960383, 11963776, 11974413, 12000788, 12069495, 12300003, 12307021, 12318714 and 12392032.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- United States, India, Japan and Slovenia.

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.

M00566490, Lot Numbers: 18893672, 11942231 and 12163810; and M00566491, Lot Numbers: 11934737 and 11996717.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- United States, India, Japan and Slovenia.

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.

M00566530, Lot Numbers: 11941297 and 11996705; and M00566531, Lot Numbers: 11941297 and 11996705.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- United States, India, Japan and Slovenia.

Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch UPN M00566530 and outer carton UPN M00566531. || 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.

UPN M00566730, Lot Numbers: 11894862, 11897679, 11899718, 11904793, 11905227, 11912161, 11913781, 11913782, 11929586, 11930733, 11935764, 11951838, 11953294, 11964849, 11967137, 11969145, 11970300, 12150268 and 12150824; and UPN M00566731, Lot Numbers: 11903831, 11906396, 11910014, 11910478, 11921219, 11921661, 11928182, 11928186, 11931538, 11939122, 11946172, 11946477, 11949498, 11957027, 11960387, 11978330, 11982282, 11985367, 12005063, 12009465, 12011789, 12019531, 12019534, 12021780, 12025626, 12296086 and 12303610.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- United States, India, Japan and Slovenia.

Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6673, inner pouch UPN M00566730 and outer carton UPN M00566731. || 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.

M00566750, Lot Numbers: 11905226, 11916062, 11963680, 12018369 and 12166919; and M00566751, Lot Numbers: 11906394, 11928185, 11949741, 11957023, 12025627, 12069497, 12300004 and 12465518.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- United States, India, Japan and Slovenia.

Boston Scientific EndoVive 20Fr (8 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6675, inner pouch UPN M00566750 and outer carton UPN M00566751. || 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.