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Medical device recalls: July 2018

The FDA posted 48 medical device recall records in July 2018, from 16 recall events by 15 companies. 1 is 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

  1. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 2 events, 10 records
  2. Covidien Medtronic · 1 event, 14 records
  3. Life Technologies, Corp. · 1 event, 6 records
  4. NewDeal SA · 1 event, 5 records
  5. Aesdex · 1 event, 2 records
  6. Medtronic Neuromodulation · 1 event, 2 records
  7. Becton, Dickinson and Company, BD Biosciences · 1 event, 1 record
  8. Canadian Hospital Specialties · 1 event, 1 record

FDA root cause

  1. Process control · 17
  2. Device Design · 11
  3. Unknown/Undetermined by firm · 6
  4. Packaging change control · 5
  5. Under Investigation by firm · 3
  6. Nonconforming Material/Component · 2
  7. Employee error · 2
  8. Labeling design · 1

Class I recalls (1)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (45)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (2)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.