9 French Super Arrow-Flex Percutaneous Sheath Introducer… recallZ-1035-03 · Arrow International Inc · initiated Jul 8, 2003
Terminated All recalls posted in July 2003
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
separation of sheath
FDA root cause category: Other
What the company is doing
The recalling firm issued recall letters dated 7/9/03 to their accounts informing them of the problem and the need to return the product. To expedite product removal the recalling firm telephoned the accounts that received the complaint lot.
Recall details
- Recall number
- Z-1035-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 8, 2003
- Posted by the FDA
- Jul 19, 2003
- Recalling firm
- Arrow International Inc
- Quantity
- 13442 units
- FDA submissions
- K940079
- Distribution
- The products were shipped to hospitals, distributors, dealers and sales representatives nationwide. The product was also shipped to export dealers in Finland, Australia, Italy, Brazil, Taiwan, New Zealand, Poland, United Kingdom, and Belgium and subsidiaries in Germany, France, Africa, Canada, Netherlands, SPain, and Greece.
Product description
9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
Code information (models, lots, serial numbers)
Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.
Other devices under the same FDA submission
15 devices cleared under K940079 — 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 IPN036336Teleflex Incorporated · INTRODUCER, CATHETER1 recall0 reports
- ARROW IPN055903Teleflex Incorporated · INTRODUCER, CATHETER1 recall0 reports
- ARROW IPN928747Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN929679Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN929716Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN929720Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN929737Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN930086Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN930576Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPNB00183Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPNB00179Teleflex Incorporated · Introducer, catheter1 recall0 reports
- ARROW IPN918404Teleflex Incorporated · INTRODUCER, CATHETER2 reports
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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