Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 115 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, and the hazard involves a risk-of-harm product (medical device malfunction) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 115 units of the EndoVive 3s Low Profile Balloon Kits (Part Number M00548560, Lot Number 929626). The recall was initiated due to a leakage issue with the feeding (reflux) valve.
The defect involves the feeding valve closing 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 product is intended to provide gastric access for enteral feeding, medication administration, and gastric decompression in adult and pediatric patients.
The affected units were distributed nationwide to Massachusetts only. Patients and caregivers using these devices 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: M00548560 (XMD P/N 70-0050-716) 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
- 115
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: M00548560 (XMD P/N 70-0050-716) Lot Number: 929626
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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- HighXeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
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- HighXeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
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