Medtronic, Inc. CATH. GUIDE 8F 3DRC W/SH LAUNC 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: LA83DRCSH Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CATH. GUIDE 8F 3DRC W/SH LAUNC 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: LA83DRCSH
Brand
Medtronic, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 0000010532 0000010592 0000025412 0000042510 0000042512 0000064172 0000076113 0000081546 0000083017 0000094114 0000097316 0000098646 0000108373 0000132346 175818 186369 201732 201960 204235
Medtronic, Inc. is recalling CATH. GUIDE 8F 3DRC W/SH LAUNC Coronary Guiding catheter designed to provide a pathway through whic 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