FDA Medical Device Recalls (openFDA)
Medtronic, Inc.: 6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 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: ZM6SR40
- Recall number
- Z-1075-06
- Recalling firm
- Medtronic, Inc.
- Product
- 6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 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: ZM6SR40
- 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
- 577 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: 0000000770 0000002134 0000028207 0000043814 0000090410 0000103759 0000125699 0000137834 0000151268 0000164481 127482 128283 128616 128988 130040 130595 132042 134208 135297 136396 138223 139414 141461 145170 152777 154356 155657 160606 166965 175986 186044 188373 204387 208088 217819 223496
- 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