Medtronic Recalls Specific CRT-P Pacemakers for Potential Malfunction

Plain-English summary

Medtronic Inc. is recalling specific units of the Consulta CRT-P (Models C4TR01, C3TR01) and Syncra CRT-P (Model C2TR01) pacemakers. The recall involves non-implanted devices manufactured between April 1 and May 13, 2013. The total quantity affected is 1,912 units, with 159 in the USA and 1,137 outside the USA.

The recall was initiated because Medtronic identified a production issue in a subset of these devices that creates a potential for malfunction. As of May 30, 2013, there have been no reported or confirmed device failures. The affected devices are sterile and were distributed worldwide, including to various US states and numerous international countries.

Physicians and distributors should return the affected non-implanted devices to Medtronic for re-inspection. Patients with implanted devices should contact their healthcare provider for guidance, as the recall specifically targets non-implanted units identified by specific serial numbers.

The recalled product

Product

Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management

Category

Medical Device — Cardiac Pacemaker

Hazard

• malfunction

Is your product affected?

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

Distribution

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