Z-1131-2022Class II

Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a...

Name: Z-1131-2022 Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a...
Creator: Medtronic Perfusion Systems
Published: 2022-04-20
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2022-04-20 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Perfusion Systems began a recall of 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... on 2022-04-20. FDA classified it as Class II and gives the reason as "Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1131-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-20
Posted: 2022-05-25
Recalling firm: Medtronic Perfusion Systems
Product: 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.
Product code: OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Reason for recall: Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A recall notification was sent to consignees on 04/20/2022 via the United Parcel Service. The letter instructs the consignees to review the updated guidance on device usage contained in the letter, share the notice to those that need to be aware, and complete the enclosed Customer Confirmation Form and email to [email protected].
Quantity in commerce: 1236 units
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1131-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1131-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-01	2022-05-25

Product code OCL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)