FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135612
- Recall number
- Z-2130-2010
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135612
- Status
- Terminated
- Initiated
- 2010-05-04
- Posted
- 2010-08-02
- Terminated
- 2012-02-01
- Reason
- 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
- 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 silvia.carrillo@crbard.com 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
- 194 units
- Distribution
- Nationwide
- Lot, serial or model codes
- LOT NUMBERS: 93FT0166, 93IT0184
- 510(k) numbers
- ["K072283"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28