FDA, Cordis recall sheath introducer due to stretching, fractures

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The FDA and Cordis have notified healthcare professionals of a U.S. recall of all lots of the Crossover Sheath Introducer, a long-coil reinforced, kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.

The recall was due to stretching or fracture of the sheath during use, according to the agency. In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity. Since the device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil creating the potential for vessel dissection or perforation.

Unplanned open surgery may be required to remove the retained segments or control bleeding, the FDA said.

To date, the Bridgewater, N.J.-based Cordis reported it has received six complaints about the Crossover Sheath Introducer. However, the company said that no permanent patient injuries have been reported. In two instances, successful surgical intervention was performed to retrieve a portion of the sheath.

The recall encompasses products distributed from Aug. 14 to Sept. 23, and includes the following lot ranges and catalog numbers:

  • Lot range: U0000025 through U0000059
  • Catalog numbers: 403545S, 403585S, 403645S, 403685S, 403745S, 403785S