The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near i
FDA device recall Z-0811-05 · posted 2005-05-10 · Terminated
Recall details
- Recalling firm
- Heartport, Inc.
- Reason for recall
- Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWZ
- Quantity affected
- 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 Republi
- Date initiated
- 2005-04-12
- Date posted
- 2005-05-10
- Date terminated
- 2005-10-31
- 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 |
|---|---|---|
| HEARTPORT ENDOAORTIC CLAMP CATHETER (K974175) | Heartport, Inc. | 1997-12-16 |