Medtronic Perfusion Systems: 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, the

Is my product affected?

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.

• UPC 00613994268051
• UPC 00613994755643
• UPC 00643169983120
• UPC 00643169998117

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling 1,236 units of the Cardioblate Gemini-s Irrigated RF Surgical Ablation System due to an increase in complaints about fractured jaw tips on the device. The affected units were distributed worldwide, including throughout the United States (in California, North Dakota, Massachusetts, Idaho, Wisconsin, Kansas, Utah, Minnesota, New York, New Jersey, Georgia, and Missouri) and in multiple countries including Australia, Belgium, China, France, Germany, Israel, Italy, Netherlands, Poland, Singapore, and Switzerland.

The recalled devices include ablation device procedure kits (Model 49260) and clamps (Model 49351) identified by specific lot numbers and GTINs listed in the recall record. The source does not specify what remedy consumers should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. 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, Netherlands, Poland, Russian Federation, Singapore, Switzerland. Quantity: 1236 units Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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