Device recall: EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon…

Nationwide distribution to MA only.

Xeridiem Mediem Medical Devices Inc, Tucson, AZ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

The table shows 60 of 105 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

Device events that started in 2015

1,153

Share of these events in Class II

91%

Product records in this event

105

Events of the firm on the register

1

• FDA enforcement report Z-0912-2016The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Where was the product distributed?

The FDA record gives this distribution: Nationwide distribution to MA only.

What quantity of product is in FDA event 73024?

The event has 105 product records. The first record gives this quantity: 36

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many device recalls of 2015 have the same class?

91% of the 1,153 device events that started in 2015 are in Class II.