Z-0895-06

Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number...

Name: Z-0895-06 Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number...
Creator: Boston Scientific Target
Published: 2006-04-26
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-04-26 / Terminated

FDA source

Boston Scientific Target began a recall of Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number: M00317210, Product is Manufactured by: Boston... on 2006-04-26. The reason FDA records is "During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0895-06
Status: Terminated
Initiated: 2006-04-26
Posted: 2006-05-23
Terminated: 2006-12-21
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number: M00317210, Product is Manufactured by: Boston Scientific - Precision Vascular, 2405 West Orton Cir. West Valley City, UT 84119
Product code: KRA Catheter, Continuous Flush
Reason for recall: During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.
FDA root cause: Other
Action: On 4/25/06, the firm initiated the recall notification via letters explaining the reason for the recall and requesting the product be returned.
Quantity in commerce: 444 units
Distribution: The product was released for distribution to 51 consignees in US and 12 foreign consignees: Finland, Austria, Belgium, The Netherlands, Great Britain, Italy, France, Spain, Germany, Poland, Russia and Hong Kong. There were no shipments to U.S. Government facilities or Canadian distribution.
Product codes and lots: All codes.

Product code KRA

K050630Class IIPivot Steerable MicrocatheterBoston Scientific - Precision Vascular / cleared 2005-03-22

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)