Bard reveals FDA warning letter over IVC filter retrievers

C.R. Bard (NYSE:BCR) today revealed that it received a warning letter from the FDA over problems found at a pair of plants that make devices to retrieve inferior vena cava filters.

The July 12 warning letter from the FDA’s Los Angeles office “specifically cites quality systems and medical device reporting observations relating to non-conformances” found during inspections at Bard plants in Glens Falls, N.Y., and Tempe, Ariz., the company said.

The safety bureau’s findings affect “appropriate market clearance or approval” for 2 models of Bard’s recovery cone removal systems, according to a Bard regulatory filing.

Until the issue is resolved, the FDA won’t clear or approve any Class III devices “to which the non-conformances are reasonably related,” Bard said.

“The company presently has 1 such submission before the FDA, which the company does not believe is material to its business,” according to the filing.

Bard said it plans to correct the observations in the warning letter but can’t say when the matter might be resolved. Still, the situation is not expected to have a material effect on its business, Bard said.

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