Class I - Dangerous
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
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
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Philips Medical Systems Gmbh, DMC
Class I - Dangerous
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Class I - Dangerous
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
Ottobock Orthopedic Industrie
Class I - Dangerous
Some of the installed valve-inserts have a diameter smaller than the specification.
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)
Class I - Dangerous
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
The Magstim Company Limited
Class I - Dangerous
A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Signature Orthopedics Pty Limited
Class I - Dangerous
Product mix up
ATLAS Loading Car
Steris
Class I - Dangerous
The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side.
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
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)
Class I - Dangerous
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
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)
Class I - Dangerous
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Angiotech (Manan Medical Products, Inc.)
Class I - Dangerous
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Class I - Dangerous
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Class I - Dangerous
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
Angiotech (Manan Medical Products, Inc.)
Class I - Dangerous
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line