Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 189 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or property damage (such as leakage of gastric contents) are rated as Severe.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 189 units of the EndoVive 3s Low Profile Balloon Kits. The affected devices are identified by Part Number M00548530 (XMD P/N 70-0050-416) and include specific lot numbers: 911111, 915911, 920211, 919005, 920611, 928916, and 930826. The recall is classified as Class II by the FDA.
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 from the device. This malfunction can allow feeding solution or gastric contents to leak out of the device in some instances.
The affected products were distributed nationwide to Massachusetts only. The EndoVive 3s Low Profile Balloon is intended to provide gastric access for enteral feeding, medication administration, and gastric decompression in adult and pediatric patients. Consumers and healthcare providers should check their inventory for the specific part and lot numbers listed and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) 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
- 189
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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