CLASS II Device recall · Reported 29 Oct 2014 · FDA Enforcement Report
10F Fast-Cath Trio" Hemostasis Introducer recalled by St Jude Medical
St Jude Medical is recalling 10F Fast-Cath Trio" Hemostasis Introducer, distributed nationwide in the US. The recall was initiated on 14 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0108-2015
- FDA event ID
- 69499
- Recalling firm
- St Jude Medical, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Oct 2014
- FDA classified
- 21 Oct 2014
- Reported
- 29 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 14 Oct 2014 | Recall initiated by company | |
| 21 Oct 2014 | Classified by FDA | +7 days |
| 29 Oct 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.
Nationwide FloridaIndianaMassachusettsMaineNew YorkOhioRhode IslandTexasWest Virginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Batch 4641580
Where was it sold?
Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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