Medtronic, Inc. CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SA63DRC Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SA63DRC
Brand
Medtronic, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 0000040400 0000047046 0000054305 0000054306 0000063145 0000063184 0000071797 0000075774 0000082018 0000094143 0000098747 0000100009 0000106139 0000116560
Medtronic, Inc. is recalling CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed due to Potential for non-sterility due to loss of package integrity. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for non-sterility due to loss of package integrity
Recommended Action
Per FDA guidance
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026