Z-0175-2010

Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model...

Name: Z-0175-2010 Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model...
Creator: Boston Scientific Corp
Published: 2009-09-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-09-17 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corp began a recall of Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model... on 2009-09-17. The reason FDA records is "The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0175-2010
Status: Terminated
Initiated: 2009-09-17
Posted: 2009-11-11
Terminated: 2010-10-08
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.
Product code: FFK Lithotriptor, Electro-Hydraulic
Reason for recall: The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by letter titled "Urgent Medical Device Recall-Immediate Action Required" dated 9/17/09 and instructed to cease using the product and to call the firm's customer service for return authorization. For additional information, call the firm at 866-868-4004.
Quantity in commerce: 173
Distribution: Nationwide.
Product codes and lots: Lots 12723202, 12745667, 12767883, 12777930, 12782625, 12808559, 12813607, 12850772 and 12861508.

Product code FFK

K012445Class IIEms Swiss Lithoclast Master (A.k.a. Swiss Lithoclast Ultra)Electro Medical Systems SA / cleared 2001-08-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)