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FDA Issues Class 1 Recall for Johnson & Johnson Heart Device


The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall for a heart device manufactured by a unit of Johnson & Johnson. Reports indicated the recall was prompted by a valve defect.

About the Johnson & Johnson Heart Device Recall

According to the CNBC, the recall was issued Tuesday and involves the Agilis Steerable Introducer Sheath, a device used to insert and position cardiovascular catheters in the heart.

The FDA states that a valve on the device which is meant to prevent blood from flowing back through the device may be faulty and not fulfill its function.

Recalled units were manufactured and distributed between January 1 and May 5, 2017.

What Is a Class 1 Recall?

Recalls issued by the FDA fall under three classifications:

  • Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
  • Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

The FDA also recognized two other safety actions:

  • Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
  • Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.

 

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