Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 40 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak out.
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 product (medical device leakage) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 40 units of the EndoVive 3s Low Profile Balloon Kits (Part Number: M00548930, XMD P/N 70-0050-C20, Lot Number: 930133). The product is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration, and gastric decompression in adult and pediatric patients.
The recall is due to a feeding (reflux) valve leakage issue. The feeding valve may close inconsistently or in a delayed manner when an extension set is disconnected from the device. This defect allows feeding solution or gastric contents to leak out of the device in some instances.
The affected units were distributed nationwide to Massachusetts only. Patients and caregivers using these specific kits should stop using the product and contact their healthcare provider or the manufacturer for instructions on replacement or repair.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-0050-C20) 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: M00548930 (XMD P/N 70-0050-C20) Lot Number: 930133
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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