Medtronic recalls Cardioblate Gemini-S surgical ablation systems due to reported fractured jaw tips. Affected units include specific model numbers and lot numbers. Consumers should contact Medtronic for details.
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Medtronic is recalling Cardioblate Gemini-S Irrigated RF Surgical Ablation Systems after reports of fractured jaw tips. This could lead to complications during surgery if the device malfunctions. The recall affects specific model numbers and lot numbers.
The device has a jaw tip that can fracture, which may cause complications during surgical procedures. This issue is reported in the recall but does not indicate immediate danger in normal use.
Surgical professionals using the Cardioblate Gemini-S Irrigated RF Surgical Ablation System are likely affected. Those with the specific model numbers and lot numbers listed in the recall are at the highest risk.
Check for the Cardioblate Gemini-S Irrigated RF Surgical Ablation System with model numbers 49260 or 49351 and the listed lot numbers. The product comes in a plastic tray with a snap-on lid.
Identify the model number (49260 or 49351) and lot numbers from the recall list to confirm if your device is affected.
Medtronic has recalled the Cardioblate Gemini-S Irrigated RF Surgical Ablation System due to reported fractures in the jaw tips, which could lead to complications during surgery.
Contact Medtronic directly to confirm if your specific model and lot numbers are affected and to get instructions on next steps.
The recall reports fractures in the jaw tips, but the official notice does not specify immediate safety risks beyond potential surgical complications.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1131-2022 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1131-2022 from Medtronic Perfusion Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.