CLASS II Device recall · Reported 17 Sep 2014 · FDA Enforcement Report
Hancock Apical Left Ventricle Connector recalled
Medtronic Cardiovascular Surgery-the Heart Valve Division is recalling Hancock Apical Left Ventricle Connector, distributed in Maryland, Texas. The recall was initiated on 15 Aug 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-2623-2014
- FDA event ID
- 69089
- Recalling firm
- Medtronic Cardiovascular Surgery-the Heart Valve Division, Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Aug 2014
- FDA classified
- 11 Sep 2014
- Reported
- 17 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Aug 2014 | Recall initiated by company | |
| 11 Sep 2014 | Classified by FDA | +27 days |
| 17 Sep 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medtronic has decided to discontinue production and distribution of this low-volume product.
Product as listed by the FDA
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
Where it was distributed
Distributed in the states of MD and TX.
Questions about this recall
Why was it recalled?
Medtronic has decided to discontinue production and distribution of this low-volume product.
Which lots are affected?
Serial Numbers: B146341, B146350
Where was it sold?
Distributed in the states of MD and TX.
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 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 Medtronic Cardiovascular Surgery-the Heart Valve Division
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic EnVeo R Delivery Catheter System (DCS) recalled | Medtronic Cardiovascular Surgery-the Heart Valve Division | Other | PR |
| Device | CLASS I | EnVeo R Loading System recalled by Medtronic Cardiovascular | Medtronic Cardiovascular Surgery-the Heart Valve Division | Particulate Matter | Nationwide |
| Device | CLASS II | Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic recalled | Medtronic Cardiovascular Surgery-the Heart Valve Division | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |