Z-0511-06

Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free...

Name: Z-0511-06 Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free...
Creator: Boston Scientific Corp
Published: 2005-12-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-12-20 / Terminated

FDA source

Boston Scientific Corp began a recall of Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-105 on 2005-12-20. The reason FDA records is "The basket wire assembly may detach from the drive wire while in the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0511-06
Status: Terminated
Initiated: 2005-12-20
Posted: 2006-02-08
Terminated: 2007-05-01
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-105.
Product code: FFL Dislodger, Stone, Basket, Ureteral, Metal
Reason for recall: The basket wire assembly may detach from the drive wire while in the patient.
FDA root cause: Other
Action: U.S. and foreign consignees were notified via letter dated 12/20/05 and requested to return stocks on hand. Distributors were requested to notify their customers.
Quantity in commerce: 39241
Distribution: Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, South Korea, Singapore, South Africa, Spain and Sweden.
Product codes and lots: All units.

Product code FFL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)