FDA Medical Device Recalls (openFDA)
Medtronic, Inc.: CATH. GUIDE 6F SR4.0 LAUNCHER CATHETER LA6SR40 LA 6F 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 Code: LA6SR40
- Recall number
- Z-0960-06
- Recalling firm
- Medtronic, Inc.
- Product
- CATH. GUIDE 6F SR4.0 LAUNCHER CATHETER LA6SR40 LA 6F 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 Code: LA6SR40
- 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
- 2204 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: 0000001691 0000002401 0000004678 0000006402 0000008033 0000008086 0000011110 0000011142 0000011890 0000015012 0000015797 0000017345 0000017357 0000020446 0000024950 0000029702 0000030830 0000033785 0000034253 0000036895 0000037331 0000041204 0000041290 0000043403 0000048659 0000053294 0000054630 0000056728 0000057232 0000062274 0000064619 0000065904 0000069371 0000069790 0000073906 0000075670 0000077725 0000078996 0000082350 0000082375 0000091519 0000098746 0000099570 0000099926 0000100520 0000101996 0000104796 0000106153 0000109527 0000109551 0000118394 0000120012 0000124096 0000125633 0000126524 0000130020 0000132240 0000143671 0000145703 0000151226 0000151733 0000154411 0000155713 0000159964 0000167213 0000171494 0000177092 0000178653 0000181909 0000182745 0000201295 177302 179227 180264 182327 182713 184240 187927 201562 201589 204546 205579 206975 209482 209483 213369 214129 215438 218112 220078 221415 223122 223880
- 510(k) numbers
- ["K021256"]
- 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