Agency classClass IIOur severity:High FDA (Devices)·Z-1283-2022·Announced 2022-06-29

Cardiac device software recalled for inadequate electrical insulation

CardioTek EP-TRACER Software V2.x is recalled because it failed electrical safety testing for insulation. The 146 affected units were distributed worldwide.

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: This is an FDA Class II medical device recall for inadequate electrical insulation. Although no injuries or illnesses have been reported, the device presents a risk of electrical harm. This meets the criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

CardioTek EP-TRACER Software V2.x has been recalled by the FDA due to a failure in electrical safety testing. A total of 146 units are affected by this recall.

The device did not meet required standards for electrical insulation. This electrical safety defect creates a potential risk of electrical hazard during use.

The affected units were distributed worldwide, including in the United States (California, New York, and North Carolina) and in 28 additional countries including Canada, Mexico, South Korea, Germany, Spain, Netherlands, Israel, Turkey, Chile, Ecuador, Austria, Croatia, Sweden, United Kingdom, Colombia, Italy, Portugal, Belgium, Slovenia, Brazil, Hungary, Malaysia, Poland, Finland, and Uzbekistan.

Healthcare facility administrators and professionals using this software should contact CardioTek BV for information about affected units and remediation guidance.

The recalled product

Product: CardioTek EP-TRACER Software V2.x.
Manufacturer: CardioTek BV
Category: Medical Device — Cardiac Electrophysiology
Hazard: electrical-insulation-failure
electrical-shock-risk
Affected units: 146

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)

EP-TRACER 38 UDI/DI: 04260441455418
Serial Numbers: 2019-1-01
2019-1-02
2019-1-03
2019-1-04
2019-1-05
2019-1-06
2019-2-01
2019-2-02
2019-2-03
2019-2-04
2019-2-05
2019-3-01
2019-3-02
2019-3-03
2019-3-04
2019-3-05
2019-3-06
2019-3-07
2019-3-08

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · CardioTek BV

See all →

Severe
CardioTek EP-TRACER Software Recalled for Unintentional Parameter Changes
FDA (Devices) · 2017-07-12

Same hazard · electrical insulation failure