CLASS III Device recall · Reported 9 Jan 2013 · FDA Enforcement Report
Fast-Cath Transseptal Guiding Introducer, 90, 8F recalled
St Jude Medical is recalling Fast-Cath Transseptal Guiding Introducer, 90, 8F, distributed in Florida, Kentucky, Oklahoma. The recall was initiated on 28 Mar 2012 and the FDA has classified it as Class III.
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-0617-2013
- FDA event ID
- 63855
- Recalling firm
- St Jude Medical, Saint Paul, MN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Mar 2012
- FDA classified
- 28 Dec 2012
- Reported
- 9 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 28 Mar 2012 | Recall initiated by company | |
| 28 Dec 2012 | Classified by FDA | +275 days |
| 9 Jan 2013 | Published in enforcement report | +12 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 recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Where it was distributed
US Distribution only including the states of FL, KY and OK.
Questions about this recall
Why was it recalled?
St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
Which lots are affected?
Model no. 406586 Batch no. 3619533
Where was it sold?
US Distribution only including the states of FL, KY and OK.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from St Jude Medical
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|---|---|---|---|---|---|
| Device | CLASS II | CardioMEMS Heart Failure (HF) System that consist recalled | St. Jude Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled | St. Jude Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled | St. Jude Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Merlin.net Patient Care Network recalled by St. Jude Medical | St. Jude Medical | Device Malfunction | 13 states |
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Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |