FDA Medical Device Recalls (openFDA)
C. R.Bard, Inc./Electrophysiology Division: Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)
- Recall number
- Z-0603-03
- Recalling firm
- C. R.Bard, Inc./Electrophysiology Division
- Product
- Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)
- Status
- Terminated
- Initiated
- 2003-01-08
- Posted
- 2003-02-28
- Terminated
- 2012-05-03
- Reason
- Sterile barrier maybe perforated compromising sterility of the device
- Root cause
- Packaging process control
- Action
- Bard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.
- Quantity
- 12 units
- Distribution
- Nationwide
- Lot, serial or model codes
- All lot numbers were the 4th digit contains the letter A through M. Ex. 07A''A''1234
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1000120754
- Firm city
- Billerica
- Firm state
- MA
- 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