Recall Z-0811-05 ยท DWZ Device, Biopsy, Endomyocardial
Heartport, Inc.
The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device.
| Date | May 10, 2005 (initiated Apr 12, 2005) |
| Status | Terminated |
| Reason | Guidewire is protruding through the film portion of the packages which compromises the sterility of the device. |
| Root cause | Other |
| Action | The recall was initiated on 4/8/2005. All accounts were phoned so as to cancel any scheduled surgical procedures that rely on these devices. Also the firm formally notified the hospitals in writing via letters to the Director of Material Managment, Director of OR, as well as the Director of the Cardiovascular Suite. Letters were sent via certified mail. |
| Quantity | 1029 units |
| Distribution | The devices were distributed to 70 consignees in the US and 43 international customers. The devices are distributed directly to customers (hospitals, clinics) in the US, Belgium, Canada, Czech Republic, France, Germany, Great Britain, Hungary, Israel, Italy, Netherlands, and Spain. There are no go |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974175 | HEARTPORT ENDOAORTIC CLAMP CATHETER Heartport, Inc., Dec 16, 1997 |