Arrow Super Arrow-Flex Percutaneous Sheath Introducers recallZ-1491-2009 · Arrow International Inc · initiated Feb 11, 2009
Terminated All recalls posted in June 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
FDA root cause category: Device Design
What the company is doing
Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.
Recall details
- Recall number
- Z-1491-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 11, 2009
- Posted by the FDA
- Jun 24, 2009
- Recalling firm
- Arrow International Inc
- Quantity
- 900,000 total, all products
- Product code
- DYB
- FDA submissions
- K924607
- Distribution
- Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
Product description
Arrow Super Arrow-Flex Percutaneous Sheath Introducers
Code information (models, lots, serial numbers)
All lots of Product codes listed in Z-1489-2009.
Other devices under the same FDA submission
12 devices cleared under K924607 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN000158Teleflex Incorporated · INTRODUCER, CATHETER13 reports
- ARROW IPN000149Teleflex Incorporated · INTRODUCER, CATHETER3 reports
- ARROW IPN000124Teleflex Incorporated · INTRODUCER, CATHETER2 reports
- ARROW IPN000125Teleflex Incorporated · INTRODUCER, CATHETER1 report
- ARROW IPN000131Teleflex Incorporated · INTRODUCER, CATHETER1 report
- ARROW IPN000132Teleflex Incorporated · INTRODUCER, CATHETER1 report
- ARROW IPN000138Teleflex Incorporated · INTRODUCER, CATHETER1 report
- ARROW IPN000140Teleflex Incorporated · INTRODUCER, CATHETER1 report
- ARROW IPN000141Teleflex Incorporated · INTRODUCER, CATHETER1 report
- ARROW IPN000153Teleflex Incorporated · INTRODUCER, CATHETER1 report
- ARROW IPN000145Teleflex Incorporated · INTRODUCER, CATHETER1 report
- ARROW IPN000151Teleflex Incorporated · INTRODUCER, CATHETER1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 51887).
- Z-1492-2009 · TerminatedArrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers
- Z-1494-2009 · TerminatedArrow Single Lumen CVCs (Central Venous Catheters)
- Z-1495-2009 · TerminatedArrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter)
- Z-1496-2009 · TerminatedArrow Two-Lumen Central Venous Access (MAC)
- Z-1497-2009 · TerminatedArrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters)
- Z-1498-2009 · TerminatedArrow ARROWg+ard Blue Plus Multi-Lumen CVCs (Central Venous Catheters)
- Z-1499-2009 · TerminatedArrow ARROWg+ard CVCs (Central Venous Catheters)
- Z-1502-2009 · TerminatedArrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts
- Z-1503-2009 · TerminatedArrow Peripherally Inserted Central Catheter
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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