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.
- Company
- Heartport Inc Route
- Recall Initiated
- April 12, 2005
- Posted
- May 10, 2005
- Terminated
- October 31, 2005
- Recall Number
- Z-0811-05
- Quantity
- 1029 units
- Firm Location
- Somerville, NJ
Reason for Recall
Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.
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 government accounts.
Lot / Code Info
Product Code EC1001: Lot Number, exp. date: MS020434, EXP APRIL-2005; MS0504003, EXP APRIL-2005; MS0504027, EXP MAY-2005; MS0604006, EXP MAY-2005; MS0604007, EXP MAY-2005; MS0704006, EXP JUNE-2005; MS0704015, EXP JUNE-2005; MS0804007, EXP AUGUST-2005; MS1004007, EXP OCTOBER-2005; MS1104021, EXP OCTOBER-2005; MS0105002, EXP JANUARY-2006; MS0105047, EXP FEBRUARY-2006; MS0205039, EXP FEBRUARY-2006; MS0205036, EXP MARCH-2006; MS0205041, EXP MARCH-2006; MS0205042, EXP MARCH-2006.
Root Cause
Other
Action Taken
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.