Z-2125-2010

Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135420

Name: Z-2125-2010 Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135420
Creator: Bard Peripheral Vascular Inc
Published: 2010-05-04
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2010-05-04 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135420 on 2010-05-04. The reason FDA records is "The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the...". 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-2125-2010
Status: Terminated
Initiated: 2010-05-04
Posted: 2010-08-02
Terminated: 2012-02-01
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135420
Product code: DQY Catheter, Percutaneous
Reason for recall: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The Bard Peripheral Vascular "URGENT MEDICAL DEVICE RECALL NOTIFICATION" with attached "RECALL AND EFFECTIVENESS CHECK FORM" was sent to the affected consignees beginning May 7, 2010 via FedEx. The recall notice informed the consignees of the reason for recall, the products affected and instructed them not to use or further distribute any affected product. The consignees were also instructed to call the firm's Recall Coordinator Silvia Carrillo at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at [email protected] to facilitate the expedient return of the affected products. Additionally they were asked to fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772.
Quantity in commerce: 56 units
Distribution: Nationwide
Product codes and lots: LOT NUMBERS: 93GT0144

Product code DQY

K072283Class IIDorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. / cleared 2007-09-19

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)