URGENT MEDICAL DEVICE RECALL
Medtronic Interventional Wires and ATTAIN HYBRID® Guide Wires
Model and Lot Numbers: See Attached List
October 21, 2013
Dear Risk Manager:
Medtronic has identified the potential for an issue with a specific subset of lot numbers of the Medtronic Interventional Wires and ATTAIN HYBRID® Guidewires where the PTFE (polytetrafluoroethylene) coating could delaminate and detach from the Guidewire. As a result, we are recalling the Guidewires from specific lots as noted in the attached list. This issue affects a subset of the following Medtronic Guidewires manufactured from mid April 2013:
Cougar® NITINOL WORKHORSE GUIDEWIRE
COUGAR® Steerable Guidewire
Zinger® STAINLESS STEEL WORKHORSE GUIDEWIRE
ZINGER® Steerable Guidewire
Thunder® EXTRA-SUPPORT GUIDEWIRE
THUNDER® Steerable Guidewire
ProVia® CROSSING GUIDEWIRE
ATTAIN HYBRID® Guide Wire
Delamination and detachment of the PTFE coating may lead to embolic occlusion and thrombosis in coronary, cerebral, peripheral or pulmonary vasculature. Vascular thrombosis and/or occlusion have the potential to result in irreversible damage or injury to vital organs including myocardial infarction or stroke.
Through October 15, 2013, Medtronic has received a total of four (4) complaints related to this issue. Medtronic has received no reports of patient deaths as a result of this issue.
For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with your standard patient management protocol.
Our records show that your facility has received one or more of these Guidewires, as shown in the attachment to this notification. Consequently, Medtronic requests you immediately take the following actions:
- Remove and quarantine all potentially affected Guidewires that remain in your inventory.
- Return the potentially affected Guidewires to Medtronic. A Medtronic representative can assist in facilitating the return and credit of product as necessary. If replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product.
- Complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality.
Medtronic has taken the necessary steps to prevent any future shipment of the potentially affected product. Regulatory agencies will be notified about this recall as applicable.
Please share this notification with others in your organization as appropriate. If any Guidewires within the scope of this recall have been forwarded to another facility, please notify that facility accordingly and facilitate the retrieval of the affected product.
We apologize for the inconvenience this may cause you; please be assured that patient safety and product quality remain our primary concern. Should you have any questions, please contact your Medtronic representative.
Vice President, Quality
Cardiac and Vascular Group
URGENT MEDICAL DEVICE RECALL
UPDATE: Additional Model and Lot Numbers
Medtronic Interventional Wires and ATTAIN HYBRID® Guide Wires Model and Lot Numbers
December 10, 2013
Affected Medtronic Model Numbers (additional model numbers added in December 2013 are in red):
Affected Medtronic Lot Numbers (additional lot numbers added in December 2013 are in red):