Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 326 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant injury or property damage reports, or structural defects.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 326 units of the EndoVive 3s Low Profile Balloon Kits. The affected devices are identified by Part Number M00548350 (XMD P/N 70-0050-214) and include lot numbers 911106, 915906, 919003, 920606, 928907, and 930837. 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 devices were distributed nationwide to Massachusetts only. 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. Patients and caregivers should contact their healthcare provider or the manufacturer for instructions on how to proceed.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) 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
- 326
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 →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- 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
Similar recalls
- HighEndoVive 20 Fr Feeding Tube May Obstruct During Placement
FDA (Devices) · 2024-04-17
- HighEndoVive 20Fr Push Safety PEG Kit Recall Due to Blocked Lumen Risk
FDA (Devices) · 2024-04-17
- SevereEZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk
FDA (Devices) · 2024-02-07
- SevereEZDilate Wire Guided Balloon Recalled for Device Malfunction Issues
FDA (Devices) · 2024-02-07
- HighPEG Feeding Tube Kit Recalled for Blocked Lumen Preventing Guidewire Advancement
FDA (Devices) · 2024-04-17
- HighFeeding tube kit recalled due to blocked connector preventing guidewire advancement
FDA (Devices) · 2024-04-17