FDA Medical Device Recalls (openFDA)
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 number
- Z-1074-06
- Recalling firm
- Medtronic, Inc.
- 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
- Status
- Terminated
- Initiated
- 2006-04-05
- Posted
- 2006-06-01
- Terminated
- 2007-06-20
- Reason
- Potential for non-sterility due to loss of package integrity
- Root cause
- Other
- Action
- 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.
- Quantity
- 139 units
- Distribution
- Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
- Lot, serial or model codes
- Lot Numbers: 0000005115 0000012614 0000014791 0000021492 0000049651 0000052460 0000102704 0000203280 129920 136399 138569
- 510(k) numbers
- ["K981198"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 1220452
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28