Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 36 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents 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 poses a risk of harm (leakage of gastric contents) but does not report specific injuries or deaths, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Xeridiem Mediem Medical Devices Inc. is recalling 36 units of the EndoVive 3s Low Profile Balloon Kits, Part Number M00548290 (XMD P/N 70-0050-812), Lot Number 929605. The devices are intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration, and gastric decompression in adult and pediatric patients.
The recall is due to a feeding (reflux) valve leakage issue. The feeding valve may close inconsistently or in a delayed manner when an extension set is disconnected from the device. This malfunction allows feeding solution or gastric contents to leak out of the device in some instances.
The affected units were distributed nationwide to Massachusetts only. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) 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
- 36
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: M00548290 (XMD P/N 70-0050-812) Lot Number: 929605
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.
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