FDA Medical Device Recalls (openFDA)
Xeridiem Mediem Medical Devices Inc: EndoVive 3s Low Profile Balloon Kits Part Number: M00548800 (XMD P/N 70-0050-F18) 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.
- Recall number
- Z-1007-2016
- Recalling firm
- Xeridiem Mediem Medical Devices Inc
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548800 (XMD P/N 70-0050-F18) 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.
- Status
- Terminated
- Initiated
- 2015-12-23
- Posted
- not on file
- Terminated
- 2016-10-25
- Reason
- A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
- Root cause
- Device Design
- Action
- Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customer was provided the following instructions: 1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users. 2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users. For any questions the customers is instructed to contact the firm. For questions regarding this recall call 520-882-7794.
- Quantity
- 40
- Distribution
- Nationwide distribution to MA only.
- Lot, serial or model codes
- Part Number: M00548800 (XMD P/N 70-0050-F18) Lot Number: 929722
- 510(k) numbers
- ["K142297"]
- PMA numbers
- not on file
- Product code
- PIF
- Firm FEI
- 2025851
- Firm city
- Tucson
- Firm state
- AZ
- 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