Z-1882-2009

MR Coaxial 10g x 118mm (VC10118MR)

Name: Z-1882-2009 MR Coaxial 10g x 118mm (VC10118MR)
Creator: Bard Peripheral Vas
Published: 2009-03-26
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2009-03-26 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vas began a recall of MR Coaxial 10g x 118mm (VC10118MR) on 2009-03-26. The reason FDA records is "Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure". 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-1882-2009
Status: Terminated
Initiated: 2009-03-26
Posted: 2009-08-26
Terminated: 2012-04-02
Recalling firm: Bard Peripheral Vascular Inc
Product: MR Coaxial 10g x 118mm (VC10118MR).
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Bard Peripheral Vascular, Inc. issued an "Urgent Medical Device Recall Notification" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax. For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254.
Quantity in commerce: 1,440
Distribution: Worldwide Distribution.
Product codes and lots: Lot Numbers: HUSC1250, HUSC1587, HUSC1588, HUSC1589, HUSD2646, HUSD2647, HUSD2648, HUSF1690, HUSH0816, HUSI0216 and HUSK1723.

Product code DWF

K082681Class IIVacora Vacuum Assisted Biopsy SystemC.R. Bard, Inc. / cleared 2008-10-15

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)