Device recall event

Recall event 90085: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA device recall · Class II · Open, Classified

Key facts

Recall event number 90085
Recalling firm Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall class Class II
Status Open, Classified
PMA numbers P010031, P010031S674, P980016, P980016S713

At a glance

  • 1–9 Recalled products (Z-numbers)
  • None Linked 510(k)s
  • 10–99 Recall events for this firm

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recall events

A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recall events