Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 331 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a device malfunction that allows leakage of gastric contents or feeding solution, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 331 units of the EndoVive 3s Low Profile Balloon Kits. The affected devices are identified by Part Number M00548360 (XMD P/N 70-0050-314) and include Lot Numbers 911107, 915907, 919004, 920607, 928908, and 930838. These kits were distributed nationwide to Massachusetts only.
The recall is due to a feeding (reflux) valve leakage issue. The valve may close inconsistently or with a delay when an extension set is disconnected from the device. This malfunction can allow feeding solution or gastric contents to leak out of the device in some instances.
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. It is indicated for 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. Patients and caregivers should contact their healthcare provider or the manufacturer for instructions on how to proceed.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) 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 End
- Manufacturer
- Xeridiem Mediem Medical Devices Inc
- Affected units
- 331
Distribution
Part of a larger recall action
This product is one of 105 recalled by Xeridiem Mediem Medical Devices Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 105 products in this recall →Related recalls
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FDA (Devices) · 2016-03-02
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