Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 77 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. The hazard involves a mechanical defect in a medical device that could lead to leakage of gastric contents or feeding solution, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 77 units of the EndoVive 3s Low Profile Balloon Kits (Part Number M00548670, XMD P/N 70-0050-218). The affected lots are 928918 and 929708. The devices were distributed nationwide to Massachusetts only.
The recall is due to a feeding (reflux) valve leakage issue. The valve may close inconsistently or with a delay when an extension set is disconnected from the device. This malfunction can allow feeding solution or gastric contents to leak out of the device.
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. Consumers should contact the manufacturer for instructions on how to proceed with the recall.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548670 (XMD P/N 70-0050-218) 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
- 77
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: M00548670 (XMD P/N 70-0050-218) Lot Numbers: 928918 929708
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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