Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 126 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 FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall involving a medical device defect that allows leakage of gastric contents or feeding solution is categorized as Severe (Score 4), as it poses a significant risk of harm.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 126 units of the EndoVive 3s Low Profile Balloon Kits, Part Number M00549420 (XMD P/N 70-0050-C22), Lot Number 923309. The FDA has classified this as a Class II recall. The devices were distributed nationwide to Massachusetts only.
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 EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration, and gastric decompression. It is indicated for adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration, or require gastric decompression and/or medication delivery directly into the stomach.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) 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
- 126
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: M00549420 (XMD P/N 70-0050-C22) Lot Number: 923309
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
Same hazard · leakage
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22