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.
FDA Recall Z-0811-05 · Posted 2005-05-10
Advertisement
Recalling FirmHeartport, Inc.
Recall StatusTerminated
Product CodeDWZ
Date Initiated2005-04-12
Date Terminated2005-10-31
Product Quantity1029 units
Reason for Recall
Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement