Z-0995-2016Class II

EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) The EndoVive 3s Low Profile...

Name: Z-0995-2016 EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) The EndoVive 3s Low Profile...
Creator: Xeridiem Mediem Medical Devices Inc
Published: 2015-12-23
License: https://open.fda.gov/license/

Xeridiem Medical Devices / initiated 2015-12-23 / Terminated / root cause: design

FDA source

Xeridiem Mediem Medical Devices Inc began a recall of EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access... on 2015-12-23. FDA classified it as Class II and gives the reason as "A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0995-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-23
Posted: 2016-02-26
Terminated: 2016-10-25
Recalling firm: Xeridiem Medical Devices
Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) 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 EndoVive 3s Low Profile Balloon is indicated for use in 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.
Product code: PIF Gastrointestinal Tubes With Enteral Specific Connectors
Reason for recall: A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Root cause tag: design
FDA root cause: Device Design
Action: Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customer was provided the following instructions: 1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users. 2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users. For any questions the customers is instructed to contact the firm. For questions regarding this recall call 520-882-7794.
Quantity in commerce: 40
Distribution: Nationwide distribution to MA only.
Product codes and lots: Part Number: M00548620 (XMD P/N 70-0050-D16) Lot Number: 929704

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0995-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0912-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0913-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0914-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0915-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0916-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0917-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0918-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0919-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0920-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0921-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0922-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0923-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0924-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0925-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0926-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0927-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0928-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0929-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0930-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0931-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0932-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0933-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0934-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0935-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0936-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0937-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0938-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0939-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0940-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0941-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0942-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0943-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0944-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0945-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0946-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0947-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0948-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0949-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0950-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0951-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0952-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0953-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0954-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0955-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0956-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0957-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0958-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0959-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0960-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0961-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0962-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0963-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0964-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0965-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0966-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0967-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0968-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0969-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0970-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0971-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0972-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0973-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0974-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0975-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0976-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0977-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0978-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0979-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0980-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0981-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0982-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0983-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0984-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0985-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0986-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0987-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0988-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0989-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0990-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0991-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0992-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0993-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0994-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0995-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0996-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0997-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0998-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0999-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1000-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1001-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1002-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1003-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1004-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1005-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1006-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1007-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1008-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1009-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1010-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1011-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1012-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1013-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1014-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1015-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-1016-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25

Product code PIF

K142297Class IIEndo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension SetXeridiem (Formerly Mri) / cleared 2015-01-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)