Xeridiem EndoVive 3s 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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 functional defect in a medical device that could lead to leakage of gastric contents or feeding solution, representing a risk of harm 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 M00549340 (XMD P/N 70-0050-422), Lot Number 930141. The recall is limited to nationwide distribution to Massachusetts only.
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, which can allow feeding solution or gastric contents to leak out of the device.
The device is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration, and gastric decompression in adult and pediatric patients. Users should contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00549340 (XMD P/N 70-0050-422) 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…
- 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: M00549340 (XMD P/N 70-0050-422) Lot Number: 930141
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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