Regulatory: Device Recalls

ICU Medical, Inc. - ChemoLock(TM) Vial Spike, - Class 1 Recall
icumedical ChemoLock(TM) Vial Spike, 20mm, REF CL-805 The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - RELIA, Dual chamber pacemaker - Class 1 Recall
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - ADAPTA, Dual chamber pacemaker - Class 1 Recall
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - SPHERA, Dual chamber pacemaker - Class 1 Recall
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - SENSIA, Dual chamber pacemaker - Class 1 Recall
Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - VITATRON, Dual chamber pacemaker - Class 1 Recall
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2

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ECMO Research

Risk-stratification enables accurate single-center outcomes assessment in congenital diaphragmatic hernia (CDH).
Author: Jancelewicz T, Paton EA, Jones J, Weems MF, Lally PA, Langham MR, Congenital Diaphragmatic Hernia Study Group
Risk-stratification enables accurate single-center outcomes assessment in congenital diaphragmatic hernia (CDH). J Pediatr Surg. 2019 Jan 31;: Authors: Jancelewicz T, Paton EA, Jones J, Weems MF, Lally PA, Langham MR, Congenital Diaphragmatic Hernia Study Group Abstract...

Moderate to Severe Acute Respiratory Distress Syndrome Management Strategies: A Narrative Review.
Author: Buckley MS, Dzierba AL, Muir J, Gonzales JP
Moderate to Severe Acute Respiratory Distress Syndrome Management Strategies: A Narrative Review. J Pharm Pract. 2019 Feb 21;:897190019830504 Authors: Buckley MS, Dzierba AL, Muir J, Gonzales JP Abstract Acute respiratory distress syndrome (ARDS) remains a common...

A dramatic learning curve of extracardiac Fontan operation in the modern era.
Author: Korun O, Çiçek M, Yurdakök O, Hekim Yılmaz E, Çelebi A, Yurtseven N, Şaşmazel A, Ali Aydemir N
A dramatic learning curve of extracardiac Fontan operation in the modern era. Asian Cardiovasc Thorac Ann. 2019 Mar;27(3):172-179 Authors: Korun O, Çiçek M, Yurdakök O, Hekim Yılmaz E, Çelebi A, Yurtseven N, Şaşmazel A, Ali Aydemir N Abstract BACKGROUND: This study...