Lot/Batch Number: 13432642

Anesthesiology Devices

2

Yes

Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden

Boston Scientific Ultraflex Covered Tracheobronchial Stent System -- Distal Release (10/4/2.5) || Material/UPN/Catalog Number: M00564760

Lot/Batch Number: 13473372

Anesthesiology Devices

2

Yes

Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden

Boston Scientific Ultraflex Covered Tracheobronchial Stent System - || Distal Release (14/4/2.5) || Material/UPN/Catalog Number: M00564800

Lot/Batch Number: 13439023

Anesthesiology Devices

2

Yes

Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden

Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (16/6/4.5) || Material/UPN/Catalog Number: M00564840

Lot/Batch Number: 13433240

Anesthesiology Devices

2

Yes

Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden

Boston Scientific Ultraflex Covered Tracheobronchial Stent System - || Distal Release (18/4/2.5) || Material/UPN/Catalog Number: MOO564860

Lot/Batch Number: 13432371, 13436055

Anesthesiology Devices

2

Yes

Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden

Boston Scientific Ultraflex Covered Tracheobronchial Stent System - || Distal Release (20/6/4.5) || Material/UPN/Catalog Number: M00564900

Lot/Batch Number:  13432574

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden

Boston Scientific Ultraflex Precision Colonic Stent System || Material/UPN/Catalog Number: M00557360

Batch numbers 13215033 and 13192372, Catalog/product UPN number M003WE0300150

Neurological Devices

HDE

Yes

International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey.

Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA || Indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with less than or equal to 50% stenosis that are accessible to the system.

A019995 A020132 A020240

Cardiovascular Devices

3

Yes

Distributed in the US to MA and PR.

Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). || Intended to provide defibrillation therapy.

Serial numbers 224020, 224209, 224322, 224366, and 224506

Cardiovascular Devices

3

Yes

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

RESONATE EL ICD VR, Model D432, Sterile.

Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767.

Cardiovascular Devices

3

Yes

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

RESONATE EL ICD DR, Model D433, Sterile.

Serial numbers 174170, 174349, 174598, and 174606.

Cardiovascular Devices

3

Yes

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

VIGILANT X4 CRT-D, Model G247, Sterile. || Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

Serial numbers 377292, 377337, 377341, and 377347

Cardiovascular Devices

3

Yes

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

MOMENTUM X4 CRT-D, Model G138, Sterile.

Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606

Cardiovascular Devices

3

Yes

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

RESONATE X4 CRT-D, Model G447, Sterile.

Cardiovascular Devices

3

Yes

Nationwide Distribution -- United States including Puerto Rico.

Boston Scientific Liberte¿¿ Monorail¿ and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". || The Liberte¿¿ Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte¿ Monorail¿ (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte¿ system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation.