DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The produ
FDA device recall Z-0309-04 · posted 2004-01-09 · Terminated
Recall details
- Recalling firm
- Heartport Inc
- Reason for recall
- Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Action taken
- Recall was first initiated on/about 10/2/03 by phone domestically from the Director of Marketing to the firm''s Sales Force (no phone script available). Following the initial phone call, formal recall letters were sent out on 10/6/03 to: Director of CV Suite; Director of the OR; and Director of Material Management of each hospital.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 151 units
- Distribution
- Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Isra
- Date initiated
- 2003-10-02
- Date posted
- 2004-01-09
- Date terminated
- 2005-10-19
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACLOK SYRINGE (K994253) | Merit Medical Systems, Inc. | 2000-01-05 |
| DIRECTFLOW ARTERIAL CANNULA (K990772) | Heartport, Inc. | 1999-03-23 |
| HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER (K974736) | Heartport, Inc. | 1998-07-15 |
| HEARTPORT INTRODUCER SHEATH (K972570) | Heartport, Inc. | 1997-10-01 |
| HEARTPORT ENDOARTERIAL RETURN CANNULA (K971291) | Heartport, Inc. | 1997-06-17 |
| HEARTPORT ENDOARTERIAL RETURN CANNUAL (K955121) | Heartport, Inc. | 1996-05-10 |