International Medical Devices Database

Data Source

Country

Device Classification

Parent Company

Name	Date	Country	Source
Recall Or Safety Alert for AutoSet CS, AutoSet CS PaceWave, AutoSet CS2, AutoSet CS-A, VPAP Adapt, VPAP Adapt SV, VPAP Adapt SV-A, VPAP Tx, S9 AutoSet CS, S9 AutoSet CS PaceWave, S9 AutoSet CS-A , S9 AutoSet CS-A PaceWave, S9 VPAP ADAPT, S9 VPAP Adapt eASV, S9 VPAP Adapt PaceWave, S9 VPAP Tx, AirCurve 10 ASV, AirCurve 10 CS PaceWave, Lumis Tx	2015-05-27	Austria	BASG
Recall Or Safety Alert for Breast implants filled with silicone gel	2010-07-05	Austria	BASG
Recall Or Safety Alert for L-Gel Ultrasound Transmission Gel – 5 ltr & 250 mls	2012-08-21	Austria	BASG
Recall Or Safety Alert for Shelhigh BioConduit™ stentless valve, Shelhigh BioMitral™ tricuspid valve, Shelhigh BioRing™ (annuloplasty ring), Shelhigh Gold™ perforated patches, Shelhigh Injectable Pulmonic Valve System, Shelhigh Internal Mammary Artery, Shelhigh MitroFast® Mitral Valve Repair System, Shelhigh No-React® Dura Shield, Shelhigh No-React® EnCuff Patch, Shelhigh No-React® Pericardial Patch, Shelhigh No-React® PneumoPledgets, Shelhigh No-React® VascuPatch, Shelhigh No-React® Stentless Valve Conduit, Shelhigh No-React® Tissue Repair Patch/UroPatch™, Shelhigh NR2000 SemiStented™ aortic tricuspid valve, Shelhigh NR900A tricuspid valve, Shelhigh Pericardial Patch, Shelhigh Pre Curved Aortic Patch (Open), Shelhigh Pulmonic Valve Conduit No-React® Treated	2007-04-19	Austria	BASG
Recall Or Safety Alert for Emser inhalation solution	2014-02-19	Austria	BASG
Recall Or Safety Alert for Silicone Implants for plastic surgery: Mammary Implants, Pectoral Implants, Gluteal Implants, Calf Implants, Implants for Hand Surgery, Tissue Expanders, Facial Implants, Nostril Retainers, Suspension Sheet for Mammoplasty; Silicone Implants for Bariatric surgery: Gastric Balloons, Gastric Bands; Silicone Implants for Urology: Testicular Implants, Penile Implants, Vesical Conformers, Periurethral Constrictors, Tubes for Hypospadias, Vaginal Stents; Silicone Implants for General Surgery: Silicone Blocks and Sheets; Silicone Invasive Devices: Sizers for Silicone Implants	2015-09-23	Austria	BASG
Recall Or Safety Alert for In vitro Diagnostics "HIV Home Test, AIDS Rapid Test"	2010-05-26	Austria	BASG
Recall of Point	2017-02-21	Japan	PMDAJ
Recall Or Safety Alert for ABG II Modular Stems and ABG II Modular Necks	2012-06-06	Austria	BASG
Recall Or Safety Alert for ABG II Modular Stems and ABG II Modular Necks	2012-07-12	Austria	BASG
Recall Or Safety Alert for ABG II Modular Stems and ABG II Modular Necks	2013-02-13	Austria	BASG
Recall Or Safety Alert for ABG II Modular Stems and ABG II Modular Necks	2014-08-21	Austria	BASG
Recall Or Safety Alert for ABG II Modular Hip System	2013-03-25	Austria	BASG
Recall Or Safety Alert for Solysafe Septal Occluder	2010-08-09	Austria	BASG
Recall Or Safety Alert for IVAD	2008-01-08	Austria	BASG
Recall Or Safety Alert for Hedrin	2008-12-12	Austria	BASG
Recall Or Safety Alert for PDO Suture with Needles COG, PDO Suture with Needles MONO SCREW, PDO Suture with Needles MONO THREAD QUEEN, PDO Suture with Needles TORNADO, PDO Suture with Needles TORNADO SCREW	2014-09-30	Austria	BASG
Recall Or Safety Alert for Yukon Choice DES and Yukon Chrome DES	2014-10-15	Austria	BASG
Recall Or Safety Alert for Kendall Monoject Syringes - Toomey Tip 60 ML	2009-02-05	Austria	BASG
Recall Or Safety Alert for W&H Alegra turbine handpiece TE-95	2013-06-27	Austria	BASG
Recall Or Safety Alert for Oxygen concentrators "Oxy-Tec 5" and "Oxy-Top 5"	2009-12-10	Austria	BASG
Recall of Ellipse (model CD 2377 - 36 QC)	2016-04-07	Japan	PMDAJ
Recall of (1) Evera ICD series (EveraXT ICD DR IS 1 / DF 1 DDBB 2 D 1) (2) Evera ICD series (EveraXT ICD VR IS 1 / DF 4 DVBB 2 D 4) (3) Evera ICD series (Evera XT ICD DR IS 1 / DF 4 DDB B 2 D 4)	2016-08-16	Japan	PMDAJ
Recall of (2) Fortify-Assura (CD 1259-40, CD 1259-40 Q, CD 2259-40, CD 2259-40 Q, CD 1359-40, CD 1255-40, (3) Heart Minder ST (CD 1299-40, CD 1299-40 Q, CD 2299-40, CD 2299-40 Q, CD 2259-40, (5) Unify (CD3235-40, CD3235-40Q) (6) Unify Assura (CD 3361-40, CD 3361-40C) (4) Heart Minder + (CD 1391-40C, CD 1391-40 QC, CD 2391-40 C, CD 231-40 QC) (8) QUADORA ASSURA (CD 3367-40, CD 3367-40C, CD 3367-40Q, CD 3367-40 QC) (9) Excelis CRT (CD3367-40, CD3367-40QC) (7) Unified Quadra (CD3251-40, CD3251-40Q) (11) Exelis + CRT-D (CD3389-40C, CD3389-40Q, CD3389-40QC) (11) Excises + CRT-D (CD3389-40C, CD3389-40Q, CD3389-40QC) (10) Quadra + Excellis (CD3385-40C, CD3385-40Q, CD3385-40QC) (12) Exelis Quadra (CD 3281 - 40, CD 3281 - 40 Q)	2016-10-12	Japan	PMDAJ
Recall of Semi-automatic defibrillator TEC-2500 series cardiolife S	2017-02-09	Japan	PMDAJ

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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