Medtronic, Inc. CATH. GUIDE 8F SR3.5 LAUNCHER CATHETER LA8SR35 LA 8F 100CM SR35 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 Code: LA8SR35 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CATH. GUIDE 8F SR3.5 LAUNCHER CATHETER LA8SR35 LA 8F 100CM SR35 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 Code: LA8SR35
Brand
Medtronic, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 0000008114 0000056825 0000065756 0000068482 0000099448 0000149030 216757 218174
Products Sold
Lot Numbers: 0000008114 0000056825 0000065756 0000068482 0000099448 0000149030 216757 218174
Medtronic, Inc. is recalling CATH. GUIDE 8F SR3.5 LAUNCHER CATHETER LA8SR35 LA 8F 100CM SR35 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