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.
“Medtronic Cardioblate Gemini-S Irrigated RF Ablation System Recall: Fractured Jaw Tips.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60793-medtronic-cardioblate-gemini-s-irrigated-rf-ablation-system-recall-fractured. Based on FDA recall #Z-1131-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1131-2022%22&limit=1).
The FDA announced on April 20, 2022, that Medtronic Perfusion Systems is recalling its Cardioblate Gemini-s Irrigated RF Surgical Ablation System due to fractured jaw tips. The recall affects 1,236 units distributed worldwide.
How to tell if you have it
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System (Model 49260) with GTINs 00613994268051, 00613994755643, and 00643169983120
CLAMP 49351 CARDIOBLATE GEMINI-S FT (Model 49351) with GTIN 00643169998117
The hazard
The firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since June 22, 2017. Recent brand recalls include the EOPA Cannula Recall for pinhole leaks (June 24, 2026), the Pediatric Cannula Recall for loose blood material (May 25, 2026), and the Octopus Evolution Tissue Stabilizer Recall for incorrect tube assembly (May 12, 2026). Other recent recalls of similar products include Boston Scientific Imager II Angiographic Catheters Recall for tip fracture risk (August 24, 2026), Penumbra RED 62 Reperfusion Catheter Recall for risk of fracture (July 24, 2026), and Medtronic Harmony Catheter System Recall for risk of tip detachment during procedures (May 22, 2026).
How to tell if you have this one
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.
Brand
Medtronic Perfusion Systems
Product
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number (49260 or 49351) and lot numbers from the recall list to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, ND, MA, ID, WI, KS, UT, MN, NY, NJ, GA, MO and the countries of Australia, Belgium, China, Czech Republic, France, Germany, Greece, Israel, Italy, Kazakhstan, Latvia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Idaho, Kansas, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Dakota, Utah, Wisconsin.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1131-2022 (April 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1131-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.