Z-0603-03

Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)

Name: Z-0603-03 Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)
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 PV Steerable Catheter Item #: 320100 (Marketed in Europe Only) 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-0603-03
Status: Terminated
Initiated: 2003-01-08
Posted: 2003-02-28
Terminated: 2012-05-03
Recalling firm: Boston Scientific Corporation
Product: Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)
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: 12 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)