Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S

Is my product affected?

Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibr

• UPC 00643169018099

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Inc. is recalling approximately 290,086 implantable cardioverter defibrillator (ICD) units from its Evera family, including models Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, and Evera XT VR. The devices affected are from a specific subset of units distributed worldwide, including throughout the United States and Puerto Rico. A small percentage of these implanted cardiac devices may experience a shortened time interval between when the device first signals that replacement is recommended and when it reaches the end of its service life.

The recall affects devices with specific serial numbers beginning with "BWC" and identifies particular lot codes. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

Details from the source

Reason for recall: A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation Distribution: Worldwide Distribution: US (nationwide) Including Puerto Rico and countries of: Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, E Quantity: 290086 units Lot/code info: 1) Evera Family: MODEL NUMBER / NAME / GTIN: SERIAL NUMBERS: DDBB1D1 / ICD-DR DDBB1D1 EVERA XT US IS1/DF1 / 00643169018099: BWC231766H, BWC230184H, BWC230891H, BWC228489H, BWC232037H, BWC230770H, BWC231219H, BWC231215H, BWC231190H, BWC231202H, BWC231199H, BWC231780H, BWC231556H, BWC230255H, BWC230772H, BWC230906H, BWC231500H, BWC231572H, BWC231618H, BWC231655H, BWC231937H, BWC231942H, BWC230859H, BWC230949H, BWC231848H, BWC230918H, BWC231237H, BWC231580H, BWC230893H, BWC231576H, BWC230426H, BWC230475H, BWC230431H, BWC231494H, BWC230876H, BWC230776H, BWC228873H, BWC229321H, BWC230873H, BWC229698H, BWC230449H, BWC231452H, BWC230877H, BWC230720H, BWC231479H, BWC231482H, BWC231578H, BWC231498H, BWC229796H, BWC230863H, BWC230874H, BWC231239H, BWC230917H, BWC229337H, BWC230524H, BWC230887H, BWC231525H, BWC231240H, BWC230672H, BWC230769H, BWC232164H, BWC232196H, BWC230048H, BWC230520H, BWC231568H, BWC231671H, BWC231761H, BWC229598H, BWC230335H, BWC230889H, BWC231570H, BWC228859H, BWC230914H, BWC231346H, BWC230884H, BWC231501H, BWC229058H, BWC229697H, BWC228813H, BWC232165H, BWC230870H, BWC230901H, BWC231259H, BWC230872H, BWC231106H, BWC230195H, BWC230911H, BWC228448H, BWC229342H, BWC230535H, BWC230655H, BWC230919H, BWC231269H, BWC231480H, BWC231668H, BWC230044H, BWC228426H, BWC230910H, BWC227091H, BWC231456H, BWC229099H, BWC229101H, BWC231874H, BWC228336H, BWC230869H, BWC230730H, BWC230630H, BWC231872H, BWC231343H, BWC228800H, BWC228656H, BWC228666H, BWC229097H, BWC231944H, BWC22688

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracor2021-02-04
• Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extra2021-02-04
• Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixin2021-02-04
• Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filte2021-02-04
• Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed2021-02-04

All FDA (Device enforcement) recalls