Medical Device Recalls

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit

Heartware, Inc.

Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090

Scientia Vascular, Inc.

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

Datascope Corp.

Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K

MEDLINE INDUSTRIES, LP - Northfield

Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

Waldemar Link GmbH & Co. KG (Mfg Site)

Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter

Boston Scientific Corporation

BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

C.R. Bard Inc

Freeman Pancreatic Flexi-Stent Catalog Number: 6582

Hobbs Medical, Inc.

DeRoyal LUMBAR DISC PACK, REF 89-10605.02

DeRoyal Industries Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584742;

Beaver Visitec International, Inc.

Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation

Medtronic Neuromodulation

GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging

GE Healthcare, LLC

Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

Model Number U228, VISIONIST CRT-P EL MRI

Boston Scientific Corporation

MAGNETOM Vida Fit. Model Number: 11410481.

Siemens Medical Solutions USA, Inc

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the b

Draeger, Inc.

CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A

Alcon Research LLC

ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308

Howmedica Osteonics Corp.

Flow-i C20 Anesthesia System, model 6677200

Getinge Usa Sales Inc

BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for

Angiodynamics, Inc.

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat

Abiomed, Inc.

1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG

MEDLINE INDUSTRIES, LP - Northfield

TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo

Howmedica Osteonics Corp.

Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Mevion Medical Systems, Inc.

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF):

Philips North America

MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297

MICROVENTION INC.

LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

Boston Scientific Corporation