Device Recall EndoVive

Lots 7511185, 7511184, 7423558, 7421294, 7421292, 7393128, 7411790, 7411788, 7411787, 7389202, 7410534, 7410533, 7407840, 7407839, 7407838 and 7421293.

Gastroenterology-Urology Devices

2

No

Nationwide and Panama.

Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, pull; catalog number 6820.

Lot 7406777.

Gastroenterology-Urology Devices

2

No

Nationwide and Panama.

Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, pull; catalog number 6824.

Part Number: M00548340 (XMD P/N 70-0050-114)  Lot Numbers: 911105 915905 920605 928906 930863

Gastroenterology-Urology Devices

2

No

Nationwide distribution to MA only.

EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548340 || (XMD P/N 70-0050-114) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Part Number: M00548460 (XMD P/N 70-0050-D14)  Lot Number: 929614

Gastroenterology-Urology Devices

2

No

Nationwide distribution to MA only.

EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548460 || (XMD P/N 70-0050-D14) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Part Number: M00548330 (XMD P/N 70-0050-014)  Lot Numbers: 928905 930835

Gastroenterology-Urology Devices

2

No

Nationwide distribution to MA only.

EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548330 || (XMD P/N 70-0050-014) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.