Teleflex recalling aortic balloon catheter kits after reports of injuries and one death

An Arrow International intra-aortic balloon catheter--Courtesy of Teleflex

Struggling Teleflex ($TFX) in February warned of an impending restructuring plan that will involve the usual mix of layoffs, relocations and outsourcing. The Wayne, PA, company just announced more bad news, saying that the FDA has labeled the global recall of more than 47,000 Arrow International intra-aortic balloon catheter kits and percutaneous insertion kits as a Class I corrective action.

The tag is reserved for situations 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." The scenario clearly meets that definition, for Teleflex said separation of the devices' sheath body from the sheath hub had resulted in 6 serious injuries and one death at the time of the February recall. Consequences of the mechanical failure include significant blood loss and loss of treatment, according to a release.

The release contains the affected product codes, as does the February field safety notice to medical staff and product distributors. Customers are urged to quarantine the recalled devices and contact Teleflex to arrange for their return.

Intra-aortic balloon catheters are implanted in the heart's aorta and mechanically support patients' circulatory system by inflating and deflating as needed to increase cardiac output and decrease stress on the heart.

According to Hong Kong's governmental Department of Health, the percutaneous insertion kit contains a sheath introducer, which is used by some clinicians during the implantation procedure. The recall pertains to the introducer, but does not affect other items in the insertion kit. Sheaths with an 8 French diameter made by St. Jude Medical ($STJ), Terumo and Cardinal Health's ($CAH) Cordis can be used for installation of the Arrow intra-aortic balloon catheters if needed.

Teleflex's Arrow unit makes a variety of the catheters under the UltraFlex, NarrowFlex and Rediguard and brand names.

The company reported 2015 revenues of $1.8 billion, down 1.6% (but up 5.4% when adjusting for exchange rate fluctuations). The restructuring plan will commence in Q2, resulting in a pre-tax charge of about $40 million.

- read the release
- here's the original safety notice (PDF)
- here's more from Hong Kong's Department of Health