Agency classClass IIOur severity:High FDA (Devices)·Z-1661-2014·Announced 2014-06-04

Medtronic Temporary Pacemaker Recalled for Pacing Rate Defect

Medtronic is recalling 16,337 temporary pacemakers worldwide because oxidation on internal contacts can cause the pacing rate to increase unexpectedly to 180 pulses per minute.

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. The hazard involves a medical device malfunction (unexpected pacing rate increase) which poses a risk of harm to patients, but the source text does not report specific injuries, hospitalizations, or deaths, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Inc. Cardiac Rhythm Disease Management is recalling 16,337 units of the Model 5348 Single Chamber External Pulse Generator (EPG) Temporary Pacemaker. The devices are used in clinical environments for temporary atrial or ventricular pacing and are distributed worldwide, including in the United States and numerous international markets.

The recall is due to a defect where oxidation over time develops high resistance on internal electrical connector contacts. This condition has been reported to cause the pacing rate to increase outside of the intended setting, potentially reaching the maximum setting of 180 pulses per minute (ppm).

Healthcare facilities and distributors should identify affected units by checking the serial numbers listed in the official recall notice. The source text does not specify a consumer action for the general public, as these devices are intended for use in clinical settings by medical professionals.

The recalled product

Product: Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically…
Manufacturer: Medtronic Inc. Cardiac Rhythm Disease Management
Category: Medical Device — Cardiac Pacemaker
Hazard: device-malfunction
pacing-rate-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)

serial numbers: PEP001001K
PEP001001P
PEP001002K
PEP001002P
PEP001003K
PEP001003P
PEP001004K
PEP001004P
PEP001005K
PEP001005P
PEP001006K
PEP001006P
PEP001007K
PEP001007P
PEP001008K
PEP001008P
PEP001009K
PEP001009P
PEP001010K
PEP001010P

Distribution

Distributed in 2 states:

Same manufacturer · Medtronic Inc. Cardiac Rhythm Disease Management

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Same hazard · device malfunction