Z-0602-03

Bard Orbiter ST Artrial Mapping Steerable Catheter Item Numbers 320001 7FAM00001 7FAM00010 7FAM00019...

Name: Z-0602-03 Bard Orbiter ST Artrial Mapping Steerable Catheter Item Numbers 320001 7FAM00001 7FAM00010 7FAM00019...
Creator: C. R.Bard, Inc./Electrophysiology Division
Published: 2003-01-08
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-01-08 / Terminated / root cause: packaging

FDA source

C. R.Bard, Inc./Electrophysiology Division began a recall of Bard Orbiter ST Artrial Mapping Steerable Catheter Item Numbers 320001 7FAM00001 7FAM00010 7FAM00019 7FAM0008B 7FAM0017B 320002 7FAM00002 7FAM00011 7FAM00020... on 2003-01-08. The reason FDA records is "Sterile barrier maybe perforated compromising sterility of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0602-03
Status: Terminated
Initiated: 2003-01-08
Posted: 2003-02-28
Terminated: 2012-05-03
Recalling firm: Boston Scientific Corporation
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
Reason for recall: Sterile barrier maybe perforated compromising sterility of the device
Root cause tag: packaging
FDA 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 in commerce: 6784 units
Distribution: Nationwide
Product codes and lots: All lot numbers were the 4th digit contains the letter A through M. Ex. 07A''A''1234

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)