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

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

All product recalls associated with Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF).

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Recall Summary

Total Recalls

1000

Past Year

581

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1821–1840 of 10937 recalls

CRTD Cobalt XT HF Quad (Medtronic) – Energy Output Risk (2023)

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

High

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

CRTD Compia MRI Quad (Medtronic) – Energy Output Risk (2023)

Moderate

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Immunoassay Premium Control (Randox) – Reporting Delay (2023)

1...90 919293 94...547

Page 92 of 547Next

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range

Moderate

FDAMay 4, 2023CA, IL, VA +3 more• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

MATRYX RMK KHAOS Snowmobiles (Polaris) – fire injury hazard (2023)

Fire/Burn Risk

This recall involves Polaris Model Year 2022-2023 MATRYX RMK KHAOS and PRO snowmobiles. The recalled snowmobiles were sold in black and custom color combinations. "POLARIS" or "KHAOS" is stamped on the front side paneling of the vehicles. The VIN and Model Number are located on the right side of the vehicle's frame. The following models are being recalled: RECALLED MODEL DESCRIPTION Model Year 2022 650 RMK KHAOS 146 MATRYX SLASH Model Year 2022 650 RMK PRO 155 MATRYX Model Year 2022 850 RMK KHAOS 146 MATRYX SLASH Model Year 2022 850 RMK KHAOS 155 MATRYX Model Year 2022 850 RMK KHAOS 155 MATRYX SLASH Model Year 2022 850 RMK KHAOS 163 MATRYX SLASH Model Year 2022 850 RMK KHAOS 165 MATRYX SLASH Model Year 2022 850 RMK PRO 155 MATRYX Model Year 2022 850 RMK PRO 155 MATRYX SLASH Model Year 2022 850 RMK PRO 163 MATRYX SLASH Model Year 2022 850 RMK PRO 165 MATRYX SLASH Model Year 2022 850 RMK PRO155 3" MATRYX SLASH Model Year 2022 PATRIOT BOOST RMK KHS155 MATRYX SLASH Model Year 2022 PATRIOT BOOST RMK PRO163 MATRYX SLASH Model Year 2022 PATRIOT BOOST RMK PRO165 MATRYX SLASH Model Year 2023 650 RMK KHAOS 146 SLASH Model Year 2023 650 RMK PRO 155 Model Year 2023 850 RMK KHAOS 146 SLASH Model Year 2023 850 RMK KHAOS 155 Model Year 2023 850 RMK KHAOS 155 SLASH Model Year 2023 850 RMK KHAOS 163 SLASH Model Year 2023 850 RMK KHAOS 165 SLASH Model Year 2023 850 RMK PRO 155 Model Year 2023 850 RMK PRO 155 SLASH Model Year 2023 850 RMK PRO 163 SLASH Model Year 2023 850 RMK PRO 165 SLASH Model Year 2023 9R RMK KHAOS 146 SLASH Model Year 2023 9R RMK KHAOS 155 SLASH Model Year 2023 9R RMK KHAOS 163 SLASH Model Year 2023 9R RMK KHAOS 165 SLASH Model Year 2023 9R RMK PRO 155 SLASH Model Year 2023 9R RMK PRO 165 SLASH Model Year 2023 9R RMK PRO 163 SLASH Model Year 2023 PATRIOT BOOST RMK KHAOS 163 SLASH Model Year 2023 PATRIOT BOOST RMK KHAOS 165 SLASH Model Year 2023 PATRIOT BOOST RMK KHS 155 SLASH Model Year 2023 PATRIOT BOOST RMK PRO 155 SLASH Model Year 2023 PATRIOT BOOST RMK PRO163 SLASH

High

CPSCMay 4, 2023Nationwide• Polaris Industries Inc., of Medina, Minnesota

Immunoassay Premium Level 3 (Randox) – Reporting Delay (2023)

Moderate

FDAMay 4, 2023CA, IL, VA +3 more• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Severe Weather Doorglass Inserts (ODL) – wind-borne debris risk (2023)

This recall involves severe weather doorglass inserts designed to protect homes in hurricane prone regions from the risk of wind-borne debris. The recalled glassdoor inserts were sold under the ODL, Western Reflections and Kenyon's Glass brand names. Date codes for affected products 05/01/2022 through 12/06/2022 are located on the bottom corners of the doors. The recalled doorglass inserts are often purchased by intermediate distributors and placed into completed "door and doorglass" products, such as under the Jeld-Wen brand. Home Depot Model Numbers 958012, 958045 Lowes Model Numbers 2570445, 940039, 940040, 940041, 940042, 940043, 940044, 940045, 940072, 940073, 940074, 940075, 940078, 940079, 940080, 940081, 940117, 940119, 940122, 940123, 940124, 949935, 1076439, 1076440, 1076442

High

CPSCMay 4, 2023Nationwide• ODL Inc., of Zeeland, Michigan

Gose con Sandia Sour Ale (Avery Brewing) – can explosion risk (2023)

Due to over pressurization, can may fail/explode.

Class IIModerate

FDAMay 3, 2023AZ, CO, IL +10 more• Avery Brewing Company

Legacy SmartBase (Implant Direct) – FDA Clearance (2023)

Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

Moderate

FDAMay 2, 2023Nationwide• Implant Direct Sybron Manufacturing LLC

MRI Biomet Pin Guide (Materialise) – Wrong Guide (2023)

The wrong tibia guide was included intended for a different patient case.

Moderate

FDAApr 26, 2023Nationwide• Materialise N.V. Technologielaan 15 Heverlee Belgium

HeartSine Defibrillator (HeartSine) – Battery Failure (2023)

Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.

High

FDAApr 26, 2023Nationwide• HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom