The FDA announced on Feb. 12, 2024, that ARROW INTERNATIONAL Inc. is recalling ARROW QuickFlash Radial Artery Catheterization devices due to a potentially defective component. The hazard includes arterial vasospasm and vessel injury from repeated attempts. Owners should contact the company for details.
How to tell if you have it
- Brand: ARROW
- Product: ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter)
- Part Numbers: REF AK-04220; REF ASK-04220-FMH1; REF ASK-04220-HHC; REF ASK-04220-KSP; REF ASK-04220-PSU; REF ASK-04220-UCL1; REF ASK-04500-AH; REF ASK-04500-HF-S; REF NA-04220-S1A; REF NA-04220-X1A; REF RA-04220; REF RA-04220-W
- Units affected: 1,160,470 devices
The hazard
Teleflex initiated this voluntary recall due to reports of resistance in the guidewire handle/chamber during use. The possible immediate health consequences are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
Context
GovInfoNow's records show ARROW INTERNATIONAL Inc. has 52 other recalls on record since 2017-06-01. Other recent recalls of similar products include Arrow Arterial Kits and Trays (2024-07-26), Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Recall (2024-04-29), and Arrow ErgoPack PICC Kit Recall (2023-08-10). Additional similar recalls include Arrow Radial Artery Catheter Kit Recall (2026-03-11), Arrow Hemodialysis Catheter Recall (2026-04-10), and ARROW Recalls Arterial Catheter Kits with Risk of Serious Injury from Contaminated Drugs (2026-04-21).