Device product
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.
Z-0108-2015
Product summary
- Firm
- St Jude Medical
- Event
- Event 69499
- Status
- Terminated
- Classification
- Class II
- Quantity
- 220
- Official record key
device-enforcement:Z-0108-2015
Official wording
Reason: 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.
Code information: Batch 4641580
Distribution pattern: Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.
Derived failure modes
-
Unknown
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.