Olympus Corporation of the Americas recalled 52 units of the Thunderbeat, 5 mm, 35 cm, Inline Grip on October 22, 2025. Reports of adverse events prompted the removal of this medical device from the market. The recall affects distribution in the US, Brazil, Canada, Germany, Mexico, and Japan.
Firm is initiating a removal due to continued reports of adverse events.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The Olympus Thunderbeat is a surgical device used in various medical procedures. Healthcare providers choose this device for its advanced capabilities in tissue dissection and sealing.
The device has been associated with reports of adverse events, which could pose significant risks during surgical procedures. The exact nature of these events remains unspecified but is serious enough to warrant a recall.
This recall is not part of a broader industry pattern.
The recall affects both healthcare providers and patients, creating potential risks during surgeries and necessitating immediate cessation of its use.
The model number and UDI can typically be found on the device packaging or instruction manual.
Expect a refund or replacement process to take 4-8 weeks after contacting Olympus.
Keep copies of any correspondence with Olympus, receipts, and photographs of the device for your records.
The Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip, Model No. TB-0535IC, is a surgical device involved in the recall. The device has a Unique Device Identifier (UDI) of 04953170464973. It was distributed worldwide, including the US and several international markets.
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