Z-1114-06

Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile...

Name: Z-1114-06 Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile...
Creator: Boston Scientific Corp
Published: 2006-05-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-05-19 / Terminated / root cause: packaging

FDA source

Boston Scientific Corp began a recall of Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog... on 2006-05-19. The reason FDA records is "Lack of assurance of sterility, as the sterile barrier may fail". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1114-06
Status: Terminated
Initiated: 2006-05-19
Posted: 2006-06-27
Terminated: 2007-06-20
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog number 3521.
Product code: LQR Dislodger, Stone, Biliary
Reason for recall: Lack of assurance of sterility, as the sterile barrier may fail.
Root cause tag: packaging
FDA 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.
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.
Product codes and lots: All lots. Lots 6604751, 6689295, 6802779, 6848203, 6905391, 7053955, 7098448, 7189064, 7353544, 7442998, 7592642, 7676907, 7703438, 7802899, 7852756, 7938900, 8002453, 8271737 and 8502059.

Product code LQR

K946358Class IIEndoscopic Biliary CatheterBoston Scientific Corp / cleared 1995-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)