FDA Medical Device Recalls (openFDA)
C. R.Bard, Inc./Electrophysiology Division: Bard Orbiter ST Artrial Mapping Steerable Catheter Item Numbers 320001 7FAM00001 7FAM00010 7FAM00019 7FAM0008B 7FAM0017B 320002 7FAM00002 7FAM00011 7FAM00020 7FAM0009B 7FAM0018B 320003 7FAM00003 7FAM00012 7FAM0001B 7FAM0010B 7FAM0019B 320004 7FAM00004 7FAM00013 7FAM0002B 7FAM0011B 7FAM0020B 320005 7FAM00005 7FAM00014 7FAM0003B 7FAM0012B 320006 7FAM00006 7FAM00015 7FAM0004B 7FAM0013B 320007 7FAM00007 7FAM00016 7FAM0005B 7FAM0014B 320008 7FAM00008 7FAM00017 7FAM0006B 7FAM0015B 320009 7FAM00009 7FAM00018 7FAM0007B 7FAM0016B
- Recall number
- Z-0602-03
- Recalling firm
- C. R.Bard, Inc./Electrophysiology Division
- Product
- Bard Orbiter ST Artrial Mapping Steerable Catheter Item Numbers 320001 7FAM00001 7FAM00010 7FAM00019 7FAM0008B 7FAM0017B 320002 7FAM00002 7FAM00011 7FAM00020 7FAM0009B 7FAM0018B 320003 7FAM00003 7FAM00012 7FAM0001B 7FAM0010B 7FAM0019B 320004 7FAM00004 7FAM00013 7FAM0002B 7FAM0011B 7FAM0020B 320005 7FAM00005 7FAM00014 7FAM0003B 7FAM0012B 320006 7FAM00006 7FAM00015 7FAM0004B 7FAM0013B 320007 7FAM00007 7FAM00016 7FAM0005B 7FAM0014B 320008 7FAM00008 7FAM00017 7FAM0006B 7FAM0015B 320009 7FAM00009 7FAM00018 7FAM0007B 7FAM0016B
- 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
- 6784 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