Teleflex, a Limerick-based medical-products firm, said that it expected to lose $2 million to $3 million of its consolidated revenues (5 cents to 7 cents a share) this year after one of its subsidiaries was forced to recall a catheter.
Teleflex's Arrow International unit announced today that it was recalling its 5800 Series Intra-Aortic Balloon Catheters with Super Arrow-Flex Sheath Introducer.
The recall was triggered by an increase of "stuck in sheath" reports involving the catheters. When the device becomes "stuck in sheath," the user is unable to move the catheter forward or backward, potentially causing a delay in critical therapy.
Teleflex said that the U.S. Food and Drug Administration considered this to be a Class I recall. The FDA's website indicated that products in that recall category have a reasonable probability of causing serious health problems or death.
For 2011, Teleflex, which makes medical products, said it expected to lose $5 million to $6 million in revenues (6 cents to 8 cents a share) because of the recall.