Heartport, Inc. Route 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Heartport, Inc. Route
Lot Codes / Batch Numbers
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.
Products Sold
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.
Heartport, Inc. Route is recalling The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elasto due to Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026