CLASS II ONGOING Device recall · Reported 1 Jun 2022 · FDA Enforcement Report

Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System recalled

Medtronic Perfusion Systems is recalling Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System, distributed nationwide in the US. The recall was initiated on 20 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesABLATION DEVICE 49260 PROCEDURE KIT Model 49260; GTIN: 00613994268051, Lot Numbers: 215G, 256E, 388C, 466C, 584D, 611A, 745F, 840C, 850C, 967C; GTIN: 00613994755643, Lot Numbers: 469C, 612A, 972C, 973C, GTIN: 00643169983120, Lot Numbers: 125E, 238D, 257E, 258E, 259E, 335D, 373B, 410E, 428D, 454F, 467C, 585D, 632E, 635F, 700D, 721C, 722C, 732E, 735E, 738E, 841C, 876E, 923D, 968C, 972E, 980E, 995D. CLAMP 49351 CARDIOBLATE GEMINI-S FT Model: 49351; GTIN: 00643169998117, Lot Numbers: 495F, 734E, 846D.

Quantity recalled1236 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1131-2022
FDA event ID: 90089
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN
Classification: Class II
Status: Ongoing
Recall initiated: 20 Apr 2022
FDA classified: 25 May 2022
Reported: 1 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Surgical Instruments

Timeline

20 Apr 2022	Recall initiated by company
25 May 2022	Classified by FDA	+35 days
1 Jun 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.

Where it was distributed

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, Netherlands, Poland, Russian Federation, Singapore, Switzerland.

Nationwide California Georgia Idaho Kansas Massachusetts Minnesota Missouri North Dakota New Jersey New York Utah Wisconsin

Questions about this recall

Why was it recalled?

Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.

Which lots are affected?

ABLATION DEVICE 49260 PROCEDURE KIT Model 49260; GTIN: 00613994268051, Lot Numbers: 215G, 256E, 388C, 466C, 584D, 611A, 745F, 840C, 850C, 967C; GTIN: 00613994755643, Lot Numbers: 469C, 612A, 972C, 973C, GTIN: 00643169983120, Lot Numbers: 125E, 238D, 257E, 258E, 259E, 335D, 373B, 410E, 428D, 454F, 467C, 585D, 632E, 635F, 700D, 721C, 722C, 732E, 735E, 738E, 841C, 876E, 923D, 968C, 972E, 980E, 995D. CLAMP 49351 CARDIOBLATE GEMINI-S FT Model: 49351; GTIN: 00643169998117, Lot Numbers: 495F, 734E, 846D.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic Perfusion Systems

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