Z-1618-2008

Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose...

Name: Z-1618-2008 Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose...
Creator: Boston Scientific Corp
Published: 2008-02-14
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-02-14 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corp began a recall of Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter on 2008-02-14. The reason FDA records is "Package sterile barrier may be breached, compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1618-2008
Status: Terminated
Initiated: 2008-02-14
Posted: 2008-08-30
Terminated: 2011-01-08
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: Package sterile barrier may be breached, compromising sterility.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Recall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form. If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or [email protected].
Quantity in commerce: 827 units total
Distribution: Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
Product codes and lots: Model Numbers M0042027BL0 (Lot#: 0011092878, 0011092882, 0011107097) and M0042028BL0 (Lot#: 0011036506, 0011036507, 0011036585, 0011036586, 0011043535, 0011043537, 0011046910, 0011046913, 0011049772, 0011049773, 0011054879, 0011055000, 0011059409, 0011059410, 0011061991, 0011061992, 0011065023, 0011065024, 0011069509, 0011069510, 0011073729, 0011073730, 0011078604, 0011078605, 0011081318, 0011081445, 0011083742, 0011083743, 0011087354, 0011087355, 0011088108, 0011088109, 0011096360)

Product code DRF

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)