CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report

EndoVive 3s Low Profile Balloon Kits recalled by Xeridiem Mediem Medical

Xeridiem Mediem Medical Devices is recalling EndoVive 3s Low Profile Balloon Kits, distributed nationwide in the US. The recall was initiated on 23 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: M00548890 (XMD P/N 70-0050-820) Lot Number: 923308

Quantity recalled126

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0964-2016
FDA event ID: 73024
Recalling firm: Xeridiem Mediem Medical Devices, Tucson, AZ
Classification: Class II
Status: Terminated
Recall initiated: 23 Dec 2015
FDA classified: 25 Feb 2016
Reported: 2 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

23 Dec 2015	Recall initiated by company
25 Feb 2016	Classified by FDA	+64 days
2 Mar 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

EndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD P/N 70-0050-820) 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.

Where it was distributed

Nationwide distribution to MA only.

Nationwide Massachusetts

Questions about this recall

Is EndoVive 3s Low Profile Balloon Kits recalled?

Yes. Xeridiem Mediem Medical Devices recalled EndoVive 3s Low Profile Balloon Kits on 23 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0964-2016.

Why was it recalled?

Which lots are affected?

Part Number: M00548890 (XMD P/N 70-0050-820) Lot Number: 923308

Where was it sold?

Nationwide distribution to MA only.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Xeridiem Mediem Medical Devices

All 105

Reported	Class	Recall	Company	Reason	Where
2 Mar 2016Device	CLASS II	EndoVive 3s Low Profile Balloon Kits recalled by Xeridiem Mediem Medical	Xeridiem Mediem Medical Devices	Packaging Defects	Nationwide
2 Mar 2016Device	CLASS II	EndoVive 3s Low Profile Balloon Kits recalled by Xeridiem Mediem Medical	Xeridiem Mediem Medical Devices	Packaging Defects	Nationwide
2 Mar 2016Device	CLASS II	EndoVive 3s Low Profile Balloon Kits recalled by Xeridiem Mediem Medical	Xeridiem Mediem Medical Devices	Packaging Defects	Nationwide
2 Mar 2016Device	CLASS II	EndoVive 3s Low Profile Balloon Kits recalled by Xeridiem Mediem Medical	Xeridiem Mediem Medical Devices	Packaging Defects	Nationwide
2 Mar 2016Device	CLASS II	EndoVive 3s Low Profile Balloon Kits recalled by Xeridiem Mediem Medical	Xeridiem Mediem Medical Devices	Packaging Defects	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide