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HVAD Pump Implant Kit (Heartware) – usage clarification (2023)

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Low

FDAOct 31, 2023Nationwide• Heartware, Inc.

Rocket 3 R (Triumph) – master cylinder problem (2023)

Triumph Motorcycles America, Ltd. (Triumph) is recalling certain 2020 Rocket 3 TFC, 2020-2024 Rocket 3 R, Rocket 3 GT, 2022 Rocket 3 GT Triple Black, and Rocket 3 R Black motorcycles. The rear brake master cylinder may fail to move fluid through the system properly, requiring an extended distance to stop.

Moderate

NHTSAOct 31, 2023Nationwide• TRIUMPH

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HVAD Pump Implant Kit (Heartware) – usage clarification (2023)

Rocket 3 R (Triumph) – master cylinder problem (2023)

Extensa A/S II Tire (Toyo) – tire safety concern (2023)

HVAD Pump (Heartware) – usage clarification (2023)

Dry Eye Relief (Leader) – non-sterile manufacturing (2023)

Lubricant Eye Drops (Leader) – non-sterile manufacturing (2023)

Lubricant Eye Drops (Leader) – non-sterile manufacturing (2023)

Eye Irritation Relief (Leader) – non-sterile manufacturing (2023)

Dry Eye Relief (Leader) – non-sterile manufacturing (2023)

Lubricant Eye Drops (Leader) – non-sterile manufacturing (2023)

Allstar XL Bus (Starcraft) – equipment issue (2023)

Snapshot NIR (Kent Imaging) – touchscreen unresponsive (2023)

Small DKS Kerrison System (Folsom) – unauthorized distribution (2023)

Bayside RV (Chinook) – camera malfunction (2023)

DKS Kerrison System (Folsom) – unauthorized distribution (2023)

Alinity HCV AMP Kit (Abbott) – false positive results (2023)

Solis RV (Winnebago) – seat fastener issue (2023)

Mustang (Ford) – brake fluid sensor problem (2023)

PHYSICA HPS Tibial Liner (Limacorporate) – labeling error (2023)

Cosco Activity Center – fall hazard (2023)