Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 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 involves a medical device with a functional defect that can lead to leakage of gastric contents or feeding solution. This is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 40 units of the EndoVive 3s Low Profile Balloon Kits, Part Number M00548820 (XMD P/N 70-0050-120), Lot Number 929724. The recall is limited to distribution in Massachusetts.
The recall is due to a feeding (reflux) valve leakage issue. The valve may close inconsistently or in a delayed manner when an extension set is disconnected from the device. This 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 using these devices should contact their healthcare provider for guidance.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) 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
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number: M00548820 (XMD P/N 70-0050-120) Lot Numbers: 929724
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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See all →- HighXeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
FDA (Devices) · 2016-03-02
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- HighXeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
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