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CardioTek BV recalls

CardioTek BV has 2 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 29 Jun 2022. The most frequent reason is device malfunction.

Total recalls2since 2017

Last 12 months0reported

Class I00% of total

Ongoing0latest 29 Jun 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why cardiotek bv is recalled

Device Malfunction2100%

Product types

Medical Software150%
Patient Monitors150%

By year

2022150%
2017150%

All cardiotek bv recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
29 Jun 2022Device	CLASS II	CardioTek Ep-tracer Software V2.x recalled by CardioTek BV	CardioTek BV	Device Malfunction	Nationwide
12 Jul 2017Device	CLASS II	CardioTek Ep-tracer Software V1.x recalled by CardioTek BV	CardioTek BV	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.