Recall Z-0127-06 ยท KRD Device, Vascular, For Promoting Embolization
AGA Medical Corporation
AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A s
| Date | Nov 5, 2005 (initiated Sep 1, 2005) |
| Status | Terminated |
| Reason | Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed. |
| Root cause | Other |
| Action | Urgent Recall letters, dated 09/01/05, were sent to affected customers via email, facsimile and with follow-up delivery via USPS. OUS customers were notified via Federal Express. The letter described the situation, the lots being recalled and included a response form that was to be faxed back to AGA Medical. |
| Quantity | 81 |
| Distribution | OUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031810 | AMPLATZER VASCULAR PLUG Aga Medical Corp., Sep 9, 2003 |