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Medical device recalls: March 2021

The FDA posted 22 medical device recall records in March 2021, from 8 recall events by 8 companies. 16 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

  1. Medtronic Perfusion Systems · 1 event, 10 records, 10 Class I
  2. Nuvasive Specialized Orthopedics Inc · 1 event, 3 records
  3. Smisson-Cartledge Biomedical, LLC · 1 event, 3 records, 3 Class I
  4. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 1 event, 2 records, 2 Class I
  5. Acist Medical Systems · 1 event, 1 record, 1 Class I
  6. Medical Components, Inc dba MedComp · 1 event, 1 record
  7. Siemens Healthcare Diagnostics, Inc · 1 event, 1 record
  8. Sirtex Medical Limited · 1 event, 1 record

FDA root cause

  1. Device Design · 13
  2. Under Investigation by firm · 4
  3. Component design/selection · 3
  4. Other · 1
  5. Employee error · 1

Class I recalls (16)

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

Class II recalls (6)

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

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.