Z-1472-2009

Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx...

Name: Z-1472-2009 Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx...
Creator: Arrow International Inc
Published: 2009-03-25
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2009-03-25 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road... on 2009-03-25. The reason FDA records is "The inflation arm tubing may separate from the stopcock adapter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1472-2009
Status: Terminated
Initiated: 2009-03-25
Posted: 2009-06-25
Terminated: 2010-02-01
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy catheter is intended for use in removing arterial emboli.
Product code: DXE Catheter, Embolectomy
Reason for recall: The inflation arm tubing may separate from the stopcock adapter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Arrow International issued an "Urgent Medical Device Recall" letter dated March 25, 2009 describing proper handling of the affected device. Consignees were also instructed to complete a Recall Acknowledgement and Stock Status Form and fax to Arrow International at 1-800-343-2935. Further questions should be directed to Arrow International, Customer Service Department at 1-800-523-8446.
Quantity in commerce: 6910 units (total all three products)
Distribution: Worldwide Distribution - USA and Panama.
Product codes and lots: Lot Numbers: CF8025431, CF8036321, CF8036744, CF8047808, CF8059711, CF8061823, CF8072763, CF80845363, CF8085910, CF8096987, CF8097704, CF8098581, CF8100407, CF8109030 and CF8112750.

Product code DXE

K902327Class IIEmbolectomy CatheterClincal Instruments Corp. / cleared 1991-02-25

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)