Food, drugs, devices › Medtronic Cardiovascular Surgery-the Heart Valve Division
Device recall: Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock
FDA enforcement event 69089 is a device recall by Medtronic Cardiovascular Surgery-the Heart Valve Division of Santa Ana, CA, initiated 15 Aug 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 6 Nov 2014. Initiation: voluntary: firm initiated. Medtronic Cardiovascular Surgery-the Heart Valve Division has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Cardiovascular Surgery-the Heart Valve Division, Santa Ana, CA.
Reason for recall
"Medtronic has decided to discontinue production and distribution of this low-volume product."
Distribution
"Distributed in the states of MD and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2623-2014 | 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. | 2 units | Class II | Terminated | 17 Sep 2014 |
Context
Other enforcement events for Medtronic Cardiovascular Surgery-the Heart Valve Division
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Aug 2016 | Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the n | Device | Class II | 1 |
| 15 Jul 2015 | EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve d | Device | Class I | 1 |
| 9 Jan 2014 | Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic B | Device | Class II | 1 |
All 4 events for Medtronic Cardiovascular Surgery-the Heart Valve Division
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Medtronic has decided to discontinue production and distribution of this low-volume product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in the states of MD and TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Nov 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.