Medtronic, Inc. ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 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: ZM5SR35 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 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: ZM5SR35
Brand
Medtronic, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 0000004321 0000016470
Products Sold
Lot Numbers: 0000004321 0000016470
Medtronic, Inc. is recalling ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 Coronary Guiding catheter designed to provi 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