Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 32 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 medical device malfunction 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 32 units of the EndoVive 3s Low Profile Balloon Kits, Part Number M00549460 (XMD P/N 70-0050-G22), Lot Number 930152. The recall is limited to units distributed to Massachusetts.
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 in some instances.
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. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) 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
- 32
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: M00549460 (XMD P/N 70-0050-G22) Lot Number: 930152
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
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- 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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