FDA Medical Device Recalls (openFDA)
Arrow International Inc: 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.
- Recall number
- Z-1472-2009
- Recalling firm
- Arrow International Inc
- 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.
- Status
- Terminated
- Initiated
- 2009-03-25
- Posted
- 2009-06-25
- Terminated
- 2010-02-01
- Reason
- The inflation arm tubing may separate from the stopcock adapter.
- 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
- 6910 units (total all three products)
- Distribution
- Worldwide Distribution - USA and Panama.
- Lot, serial or model codes
- Lot Numbers: CF8025431, CF8036321, CF8036744, CF8047808, CF8059711, CF8061823, CF8072763, CF80845363, CF8085910, CF8096987, CF8097704, CF8098581, CF8100407, CF8109030 and CF8112750.
- 510(k) numbers
- ["K902327"]
- PMA numbers
- not on file
- Product code
- DXE
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- 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