Medtronic, Inc. 7F ZUMA 2 SR4.0 100CM CATHETER Z27SR40 Z2 7F 100CM SR40 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: Z27SR40 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
7F ZUMA 2 SR4.0 100CM CATHETER Z27SR40 Z2 7F 100CM SR40 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: Z27SR40
Brand
Medtronic, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 0000002247 0000008188 0000015219 0000015885 0000057268 0000075237 0000103319 0000151685 0000176359 212367 221319
Medtronic, Inc. is recalling 7F ZUMA 2 SR4.0 100CM CATHETER Z27SR40 Z2 7F 100CM SR40 Coronary Guiding catheter designed to provid 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