Z-1855-2008

Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is intended for use for percutaneously...

Name: Z-1855-2008 Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is intended for use for percutaneously...
Creator: Bard Peripheral Vascular Inc
Published: 2008-05-09
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2008-05-09 / Terminated / root cause: design

FDA source

Bard Peripheral Vascular Inc began a recall of Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is intended for use for percutaneously remove the recovery filter or facilitate the... on 2008-05-09. The reason FDA records is "This action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign body". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1855-2008
Status: Terminated
Initiated: 2008-05-09
Posted: 2008-09-04
Terminated: 2009-12-10
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system.
Product code: GAE Snare, Surgical
Reason for recall: This action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign body.
Root cause tag: design
FDA root cause: Device Design
Action: On May 9, 2008, BARD began distribution of an Urgent Recall Notice with fax-back attachment to all customers in the United States via overnight carrier (FedEx). The Notice informed customers of the problem and the risks associated with the use of this product. The letter instructed their customers to check all inventory locations for the recalled product, remove and return affected product to BPV. The letter also asked their customers to share this information regarding the recall with physicians that perform procedures with the affected product at their facility. Once the product affected by the recall has been removed from their inventory, the customers were asked to contact the BPV Recall Coordinator at 1-800-321-4254 X 2727 to obtain a Return Authorization Number to facilitate replacement of the returned devices. A mailing label was enclosed to return the recalled product.
Quantity in commerce: 999
Distribution: Nationwide
Product codes and lots: All lots with expiry dates between May 2008 and February 2011. Serial Numbers: GFRL3426 GFRL3425 GFRL3438 GFRL3439 GFRL3443 GFRL3445 GFRL3448 GFRL3424 GFRL3436 GFRL3437 GFSA0555 GFSA0027 GFSA0556 GFSA0557 GFSA0560 GFSA0610 GFSA0611 GFSA0612 GFSA0613 GFSA0614 GFSA0615 GFSA0644

Product code GAE

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)