Medical device recalls: December 2018
The FDA posted 6 medical device recall records in December 2018, from 5 recall events by 5 companies. 2 are Class I, the most serious category.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- Capintec Inc · 1 event, 2 records
- Covidien LLC · 1 event, 1 record, 1 Class I
- Foundation Medicine, Inc. · 1 event, 1 record
- Medtronic Navigation, Inc. · 1 event, 1 record, 1 Class I
- The Binding Site Group, Ltd. · 1 event, 1 record
FDA root cause
- Under Investigation by firm · 3
- Device Design · 2
- Other · 1
Class I recalls (2)
The most serious: a reasonable probability that using the device will cause serious health problems or death.
- Z-0552-2019 · Medtronic Navigation, Inc. · posted Dec 29, 2018 · Terminated
An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
- Z-0497-2019 · Covidien LLC · posted Dec 18, 2018 · Terminated
Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
Class II recalls (4)
The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- FoundationOne CDx Test Results ↗Class IIZ-0649-2019 · Foundation Medicine, Inc. · posted Dec 20, 2018 · Terminated
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
- Z-0604-2019 · The Binding Site Group, Ltd. · posted Dec 13, 2018 · Terminated
Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
- Z-0550-2019 · Capintec Inc · posted Dec 4, 2018 · Terminated
There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
- Z-0551-2019 · Capintec Inc · posted Dec 4, 2018 · Terminated
There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.