St Jude Medical: Medical Device Recall in 2014 - (Recall #: Z-0108-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.

Product Classification:

Class II

Date Initiated: October 14, 2014

Date Posted: October 29, 2014

Recall Number: Z-0108-2015

Event ID: 69499

Reason for Recall:

St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.

Status: Terminated

Product Quantity: 220

Code Information:

Batch 4641580

Distribution Pattern:

Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated