Z-0030-2007

Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring...

Name: Z-0030-2007 Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring...
Creator: Arrow International Inc
Published: 2006-06-20
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2006-06-20 / Terminated

FDA source

Arrow International Inc began a recall of Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart on 2006-06-20. The reason FDA records is "The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0030-2007
Status: Terminated
Initiated: 2006-06-20
Posted: 2006-10-12
Terminated: 2006-10-16
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.
Product code: NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Reason for recall: The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.
FDA root cause: Other
Action: Recall letter was sent to customers on 6/20/2006 by US mail.
Quantity in commerce: 11 units
Distribution: Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5.
Product codes and lots: MF5124329

Product code NVM

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)