Every recall we track for Medtronic, Inc. — 98 in all — plus the complaints and injury reports the public filed about them.
Medtronic recalls Sphere-9 catheters (model AFR-00001) for patients with Biotronik ICDs or CRT-Ds due to risk of ventricular fibrillation during radiofrequency therapy. Medtronic recommends increased caution and availability of external defibrillation systems.
Medtronic recalls specific Abre Venous Self-Expanding Stent models due to a Nitinol anomaly that may reduce stent diameter and cause migration. Affected models include AB9G14120090 and others listed in the recall notice.
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Medtronic recalls specific software versions of its CareLink SmartSync Device Manager (Model 24967A) due to a potential risk during high-voltage therapy tests where users may not be able to cancel therapy properly.
Medtronic recalls specific software versions of CareLink SmartSync Patient Connector Model 24967 due to a risk of unintended high-voltage therapy delivery during induction tests. Affected units may not properly cancel high-voltage treatments if the Abort button fails to stop the test.
Medtronic recalls specific software versions for CareLink SmartSync Device Manager to prevent false electrical reset alerts that could lead to unnecessary device explant.
Medtronic recalls Azure S DR MRI SureScan devices with specific serial numbers due to potential battery failure that could lead to cardiac arrest or hospitalization. Affected units must be checked for serial numbers RNJ108800G to RNJ108820G.
Medtronic recalls 2090 Programmers with serial number prefixes PKK0 and PKK1 that may move cursor autonomously when Finger Touchscreen is enabled in software version 3.2 or higher. Affected units include specific model variants and GTINs.
Medtronic recalls Evera MRI S DR SureScan defibrillators with model DDMC3D1 due to potential weld cracks causing failure during manufacturing leak checks. Affected units have specific serial numbers and GTIN.
Medtronic recalls MIRRO MRI DR SureScan implantable defibrillators with model DDME3D1 due to potential welding cracks causing manufacturing failures. Affected units have specific serial numbers and GTIN.
Medtronic recalls specific implantable defibrillators (model DTPA2Q1) due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTINs. Contact Medtronic for details.
Medtronic recalls specific models of PRIMO MRI VR SureScan implantable defibrillators due to potential welding cracks causing manufacturing failures. Affected units have unique serial numbers.
Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTINs.
Medtronic recalls specific Cobalt XT HF CDT-D MRI SureScan defibrillators with model DTPA2D4 due to potential welding cracks causing manufacturing failures. Affected units have unique serial numbers and GTIN.
Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTINs. Contact Medtronic for details.
Medtronic recalls specific Implantable Cardioverter Defibrillators (COBALT XT HF QUAD CRT-D MRI SureScan) with model DTPA2QQ due to potential welding cracks causing device failure during manufacturing leak checks.
Medtronic recalls specific implantable cardioverter defibrillators with potential manufacturing defects that could cause device failure during leak checks.
Medtronic recalls Evera S VR implantable defibrillators (model DVBC3D1) due to potential weld cracks causing manufacturing failures. Affected units have specific serial numbers and GTIN.
Medtronic recalls specific implantable defibrillators due to potential welding cracks causing manufacturing failures. Affected models include DTPA2D1 with serial numbers starting with RTH608902S.
Medtronic recalls specific MIRRO MRI VR SureScan implantable defibrillators due to potential welding cracks causing manufacturing failures. Affected units have model DVME3D1 and serial numbers listed. No remedy provided in official recall.
Medtronic recalls specific Implantable Cardioverter Defibrillators (PRIMO MRI DR SureScan Model DDMD3D1) due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTIN.
Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTINs. Contact for return or repair options.
Medtronic recalls specific MIRRO MRI DR SureScan implantable defibrillators due to potential welding cracks causing manufacturing failures. Affected units have unique serial numbers and GTINs.
Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTINs.
Medtronic recalls specific models of implantable cardioverter defibrillators due to potential weld cracks causing manufacturing failures. Affected units include model DDPB3D4 with listed serial numbers and GTINs.
Medtronic recalls specific MIRRO MRI VR SureScan defibrillators (model DVME3D4) due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers listed in the recall notice.
Medtronic recalls COBALT XT VR MRI SureScan defibrillators with model DVPA2D1 due to potential weld cracks causing manufacturing failures. Affected units have specific serial numbers and GTIN.
Medtronic recalls Cobalt XT DR MRI SureScan defibrillators with model DDPA2D1 due to potential weld cracks causing manufacturing failures. Affected units have specific serial numbers and GTIN.
Medtronic recalls specific Implantable Cardioverter Defibrillators (COBALT HF QUAD CRT-D MRI SureScan) with model DTPB2QQ due to potential welding cracks causing failure during manufacturing leak checks.
Medtronic recalls specific Implantable Cardioverter Defibrillators (COBALT DR MRI SureScan model DDPB3D1) due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTIN.
Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers; contact Medtronic for details.
Medtronic recalls specific Abre Venous Self-expanding Stent Systems due to potential sterile package breach. Affected product numbers include AB9U14080090, AB9U18100090, and AB9G14100090. No remedy is specified in the recall notice.
Medtronic recalls Cobalt XT DR MRI SureScan defibrillators with product number DDPA2D1 due to potential battery retesting during quality checks, which may affect safety.
Medtronic recalls Protege GPS Self-Expanding Peripheral Stent System (product number SERB65-09-60-80) due to potential packaging seal defects that could compromise sterility. Affected units include lot B644679 with UDI-DI 00643169728974.
Medtronic recalls specific models of ICM LNQ22 LINQ II insertable cardiac monitors due to potential signal interference that may affect heart rhythm recordings. This issue differs from normal noise patterns caused by device movement or external factors.
Medtronic recalls Mo.Ma Ultra Proximal Cerebral Protection Device model MUS0130069X6 due to incorrect labeling of arterial inflation ports, potentially causing misidentification during medical procedures.
Medtronic recalls Mo.Ma Ultra Proximal Cerebral Protection Device model MOM0130068X5 due to incorrect port labeling that may cause misidentification during use. Affected units have superior labels on both sides of the manifold.
Medtronic recalls Mo.Ma Ultra Proximal Cerebral Protection Device model MOM0130069X6 due to incorrect port labeling that could lead to improper use during medical procedures.
Medtronic recalls EverFlex Self-Expanding Peripheral Stents with Entrust Delivery System due to potential partial deployment risks. Affected models include 158 specific model numbers and GTINs.
Medtronic recalls Sprinter OTW catheter model SPR2512W due to incorrect balloon size labeling on the Luer connector. This may lead to improper sizing during procedures. Affected units were sold with specific lot numbers.
Medtronic recalls HeartWare Battery Model 1650DE (serial numbers listed) due to weld defect causing battery malfunction. No power or improper charging may occur.
Medtronic recalls HeartWare HVAD Pump Implant Kit models 1104JP and MCS1705PU due to suspected welding defects that could cause pump malfunction and affect blood flow.
Medtronic recalls instructions for use, patient manuals, and emergency responder guides for HeartWare Ventricular Assist Device (HVAD) systems due to errors and inconsistencies in documentation. Affected models include specific pump implant kits and catalog numbers.
Medtronic recalls Harmony Delivery Catheter System (HARMONY-DCS) due to potential capsule bond breaking during TPV valve replacement procedures. Affected lots listed in the recall notice.
Medtronic recalls VenaSeal Closure System models SP-101 and VS-402/404 due to adhesive not advancing through delivery catheter. Affected units have specific serial numbers listed in the recall notice.
Medtronic recalls Abre Venous Self-expanding System due to incorrect size printed on device, packaging labeled correctly. Affected units may have size mismatch risks.
Medtronic recalls Enlite Glucose Sensors for patients using hydroxyurea, which may cause inaccurate elevated glucose readings. Affected units have specific packaging labels.
Medtronic recalls Guardian Sensor (3) devices for inaccurate elevated glucose readings when used with hydroxyurea. Affected units have specific packaging codes. Contact Medtronic for details.
Medtronic recalls Enlite Glucose Sensors (GTINs 00643169541719, 00643169786738, 00763000421304) that may give inaccurate high glucose readings when used with hydroxyurea. Affected users should contact Medtronic for details.
Medtronic recalls Enlite Glucose Sensors for potential inaccurate elevated readings when used with hydroxyurea. Affected units include specific packaging and lot numbers. Consumers should consult the recall notice for details.
Medtronic recalls Guardian Sensor (3) models for potential inaccurate glucose readings when used with hydroxyurea. This could lead to unsafe blood sugar levels for patients taking this chemotherapy drug.
Medtronic recalls Guardian Sensor (3) models with specific packaging for inaccurate glucose readings when using hydroxyurea. Affected users should contact Medtronic for details.
Medtronic recalls Guardian Sensor (3) models for potential inaccurate glucose readings when used with hydroxyurea. Affected units have specific packaging labels. No immediate action needed but check your device.
Medtronic recalls Guardian Sensor (3) devices for potential inaccurate glucose readings when used with hydroxyurea medication. Affected units have specific packaging details. Contact Medtronic for remedy.
Medtronic recalls Guardian Sensor (3) devices for Canada with GTIN 20763000179612. Inaccurate glucose readings may occur when using hydroxyurea, an anti-cancer drug. No remedy specified in recall notice.
Medtronic recalls Guardian Sensor (3) for potential inaccurate glucose readings when used with hydroxyurea. Affected units have specific packaging details. Contact Medtronic for remedy.
Medtronic recalls Guardian Sensor (3) devices for inaccurate elevated glucose readings when used with hydroxyurea. Affected units have specific packaging details. Contact Medtronic for remedy.
Medtronic recalls Guardian Sensor (3) for potential inaccurate glucose readings when used with hydroxyurea. Affected units sold in Canada with specific packaging. No remedy stated.
Medtronic recalls Enlite Glucose Sensors for patients on hydroxyurea, which may cause inaccurate elevated glucose readings. Affected units have specific packaging codes.
