Medtronic, Inc. 6F ZUMA SR3.5 CATHETER ZM6SR35 ZM 6F 100CM SR3.5 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: ZM6SR35 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
6F ZUMA SR3.5 CATHETER ZM6SR35 ZM 6F 100CM SR3.5 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: ZM6SR35
Brand
Medtronic, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 0000005115 0000012614 0000014791 0000021492 0000049651 0000052460 0000102704 0000203280 129920 136399 138569
Medtronic, Inc. is recalling 6F ZUMA SR3.5 CATHETER ZM6SR35 ZM 6F 100CM SR3.5 Coronary Guiding catheter designed to provide a pa 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