The Recall Desk
HighFDA (Devices)·Z-1131-2022·Announced 2022-06-01

Medtronic Cardioblate Gemini-s Surgical Ablation System Recalled for Fractured Jaw Tips

Medtronic is recalling 1,236 units of the Cardioblate Gemini-s surgical ablation system due to an increase in complaints about fractured jaw tips. The device is used in cardiac ablation procedures worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving a surgical ablation system with a reported structural defect (fractured jaw tips). No illnesses or injuries have been reported in the source material, meeting the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Perfusion Systems is recalling 1,236 units of the Cardioblate Gemini-s Irrigated RF Surgical Ablation System due to an increase in complaints related to fractured jaw tips. The device is a surgical instrument used in cardiac ablation procedures.

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. The recall also affects units distributed to Australia, Belgium, China, Czech Republic, France, Germany, Greece, Israel, Italy, Kazakhstan, Latvia, Netherlands, Poland, Russian Federation, Singapore, and Switzerland. Specific lot numbers have been identified and are included in the recall.

Patients and healthcare providers who have devices from the affected lot numbers should contact Medtronic Perfusion Systems for further instructions regarding their devices.

The recalled product

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.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Surgical Ablation System
Hazard
  • jaw-tips-fracture
  • device-structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

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