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Heartstring Proximal Seal System (Maquet) – Deployment Failure (2025)

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

High

FDAAug 15, 2025Nationwide• Maquet Cardiovascular, LLC

STRATAFIX Surgical Device (Ethicon) – Barb Non-Engagement (2025)

Potential for barb non-engagement.

Low

FDAAug 15, 2025Nationwide• ETHICON, LLC

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Heartstring Proximal Seal System (Maquet) – Deployment Failure (2025)

STRATAFIX Surgical Device (Ethicon) – Barb Non-Engagement (2025)

Raw Frozen Shrimp (Beaver Street Fisheries) – cesium contamination (2025)

Whiting Fillet (Stanley Pearlman) – incorrect date labeling (2025)

1L Carbonation Bottles (Drinkmate) – impact and laceration hazard (2025)

Electronic LED Modules (Viewrail) – fire hazard (2025)

Petite Tea Kettles (Wolfgang Puck) – burn hazard (2025)

Multi-Max Pro Ladders (Werner) – fall hazard (2025)

HaloLock Wireless Power Banks – fire and burn risk (2025)

Remington Hair Dryer – electrocution risk (2025)

Spiral Tower Toys (Unknown) – choking risk (2025)

Safe & Green Fuel Bottles (Firefly) – serious injury risk (2025)

Jeep Wrangler (Jeep) – Tire Pressure Sensing Problem (2025)

Breaded Shrimp (AquaStar) – Cesium-137 contamination (2025)

Altec Digger Derrick (Altec) – Winch Bumper Fastener Issue (2025)

Jayco Jay Flight SLX (Jayco) – Missing Furnace Vent (2025)

Kroger Cooked Shrimp (AquaStar) – Cesium-137 contamination (2025)

AquaStar Cocktail Shrimp (Admiralty Island) – Cesium-137 contamination (2025)

UniCel DxH 900 Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Volkswagen Tiguan (Volkswagen) – Tie Rod Bolt Issue (2025)