Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution when disconnected.
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 defect that poses a risk of harm (leakage of gastric contents/feeding solution) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 40 units of the EndoVive 3s Low Profile Balloon Kits (Part Number M00549450, Lot Number 930151). The recall is due to a leakage issue with the feeding (reflux) valve. The valve may close inconsistently or with a delay when an extension set is disconnected, which can allow feeding solution or gastric contents to leak out of the device.
The affected devices were distributed nationwide to Massachusetts only. 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 in adult and pediatric patients who require long-term feeding or are unable to tolerate oral feeding.
Consumers and healthcare providers should stop using the affected devices and contact Xeridiem Mediem Medical Devices Inc for further instructions.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-0050-F22) 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: M00549450 (XMD P/N 70-0050-F22) Lot Number: 930151
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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