FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0811-05
- Recalling firm
- Heartport, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2005-04-12
- Posted
- 2005-05-10
- Terminated
- 2005-10-31
- 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 government accounts.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K974175"]
- PMA numbers
- not on file
- Product code
- DWZ
- Firm FEI
- 3000719637
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28