Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 186 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, and the hazard involves a risk of harm (leakage of gastric contents) where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 186 units of the EndoVive 3s Low Profile Balloon Kits, Part Number M00548540 (XMD P/N 70-0050-516). The affected lots are 911112, 915912, 919006, 920612, and 929624. 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 defect can allow feeding solution or gastric contents to leak out of the device in some instances.
The product was 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 who require long-term feeding or are unable to tolerate oral feeding.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) 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
- 186
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
Same manufacturer · Xeridiem Mediem Medical Devices Inc
See all →- HighXeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
FDA (Devices) · 2016-03-02
- HighXeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
FDA (Devices) · 2016-03-02
- HighXeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
FDA (Devices) · 2016-03-02
- HighXeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
FDA (Devices) · 2016-03-02
- HighXeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
FDA (Devices) · 2016-03-02
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