Agency classClass IIOur severity:High FDA (Devices)·Z-1607-2013·Announced 2013-07-03

Medtronic Recalls Specific CRT-P Pacemakers for Potential Malfunction

Medtronic is recalling specific Consulta and Syncra CRT-P pacemakers manufactured in April and May 2013 due to a production issue that could cause malfunction. No device failures have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall is classified as FDA Class II, and the source explicitly states that no device failures have been reported. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

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.

Lot numbers (20)

UPDATED 7/18/2013: Serial Numbers: PVX610233S
PVX610234S
PVX610253S
PVX610258S
PVX610296S
PVX610302S
PVX610308S
PVX610311S
PVX610312S
PVX610313S
PVX610314S
PVX610315S
PVX610317S
PVX610318S
PVX610319S
PVX610320S
PVX610321S
PVX610323S
PVX610324S
PVX610325S

Distribution

Distributed in 25 states:

Same manufacturer · Medtronic Inc. Cardiac Rhythm Disease Management

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Same hazard · malfunction