FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513.
- Recall number
- Z-1110-06
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513.
- Status
- Terminated
- Initiated
- 2006-05-19
- Posted
- 2006-06-27
- Terminated
- 2007-06-20
- Reason
- Lack of assurance of sterility, as the sterile barrier may fail.
- Root cause
- Other
- Action
- Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.
- Quantity
- not on file
- Distribution
- Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
- Lot, serial or model codes
- All lots. Lots 558552, 7739212, 602212, 7753189, 6593723, 7794743, 6632145, 7814338, 6666397, 7836676, 6685227, 7864847, 6713444, 7885211, 6732190, 7938898, 6746552, 7959197, 6787368, 7979136, 6795091, 7997847, 6834079, 8001283, 6846985, 8079834, 6874028, 8119586, 6897533, 8133511, 6900226, 8170294, 6948065, 8203324, 6966289, 8250997, 6987748, 8306742, 6988354, 8306923, 7037239, 8409135, 7052984, 8430041, 7078441, 8459615, 7189065, 8533268, 7213471, 7244925, 7323059, 7351026, 7403584, 7442556, 7485763, 7536756, 7557104, 7656402, 7675613, 7701170 and 7722953.
- 510(k) numbers
- ["K946358"]
- PMA numbers
- not on file
- Product code
- LQR
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- 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