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Ann Med Surg (Lond)
Ann Med Surg (Lond)
MS9
Annals of Medicine and Surgery
2049-0801
Lippincott Williams & Wilkins Hagerstown, MD

AMSU-D-24-00819
10.1097/MS9.0000000000002364
00005
3
Editorials
FDA announces recall of over 300 000 arrow radial artery catheterization kits: a call for action – an editorial
Jain Hritvik MBBS ahritvikjain2001@gmail.com

Jain Jyoti MBBS dr.jyotijain18@gmail.com
a
Odat Ramez M. MD cDr.RamezOdat@gmail.com

Goyal Aman MBBS bamanmgy@gmail.com

Yadav Rukesh MBBS d*rukeshyadav46@gmail.com

a Department of Internal Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur
b Department of Internal Medicine, Seth GS Medical College and KEM Hospital, Mumbai, India
c Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan
d Department of Internal Medicine, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University, Nepal
* Corresponding author. Address: Department of Internal Medicine, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University 44600, Nepal. Tel.: +977 984 953 6451 E-mail: rukeshyadav46@gmail.com (R. Yadav).
9 2024
12 7 2024
86 9 49524953
24 4 2024
3 7 2024
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
2024
https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0/

OPEN-ACCESSTRUE
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pmcOn 4 April 2024, the Food and Drug Administration (FDA) identified ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits as causing serious adverse events and even death in over 194 registered complaints. Hence, the FDA issued a warning to recall these catheterization kits and avoid their further usage, considering this as a ‘Class I recall’, the most serious type of recall1. Radial artery catheterization is a commonly performed intervention in critical cases for intensive hemodynamic monitoring and vasopressor administration, particularly in cases of shock. Arterial blood catheters also provide direct access for frequent blood gas analyses in patients on ventilatory support for continuous monitoring. Venous catheters are also frequently used; however, their limitations include an increased risk of infection, bleeding, venous obstruction, cardiac tamponade, emboli, and sepsis2. Although arterial lines are also associated with the aforementioned adverse events, they offer a much more accurate measurement of blood pressure3. Arterial blood pressure wave analysis is critical in making informed decisions, particularly in severely hypotensive patients on external life support4. Despite its importance, the failure rates of radial arterial catheters are greater than 25% and include complications such as loss of catheter function, absence of blood return, dislodgement, and unanticipated stoppage of hemodynamic monitoring5.

The Arrow QuickFlash Arterial Catheter is a type of arterial catheter composed of integrated wings, hydrophilic coating, flashback windows, blood containment, and a removable guidewire. The Arrow QuickFlash catheter was marketed under the impression that it allowed for the rapid identification of the return of blood and reduced arterial transfixation. Teleflex claimed the Arrow QuickFlash arterial catheter to have quick handling (easy insertion with one hand), quick visualization, quick safety procedures (minimizing blood exposure), and quick alternative techniques using guidewire repositioning6. However, Teleflex received over 190 reported complaints concerning increased resistance in the guidewire handle, which obstructed its free use during the intervention. These complaints were reports of adverse events such as injury to the arterial vessel walls, vasospasm, embolism, and death. In contrast, other brands of arterial catheters have their own sets of complications but typically report fewer complaints of such severe outcomes. For example, while complications such as catheter dislodgement and infection are common across other brands such as RadiaFlo and McKesson, the specific problem of guidewire resistance leading to severe vascular injury and embolism appears more frequently in Arrow QuickFlash catheters. On 12 February 2024, Teleflex and Arrow issued an Urgent Recall letter to hospitals and distributors to refrain from using ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits to avoid serious outcomes among recipients of these devices. FDA recommended quarantining such catheterization kits to avoid mistaken usage1.

This current editorial highlights the pitfalls of Arrow catheterization kits and is a call to action that warns cardiovascular clinicians to refrain from cannulating patients with the aforementioned catheter.

Ethical approval

The information provided in the manuscript does not require an ethics application or approval.

Consent

No patients were sorted. Informed consent was not required for this manuscript.

Source of funding

No funding was received.

Author contribution

H.J.: conceptualization, methodology, supervision, and writing – review and editing; J.J.: supervision, investigation, writing – original draft, and writing – review and editing; R.M.O.: resources, project administration, writing – original draft, and writing – review and editing; A.G.: validation, writing – original draft, and writing – review and editing; R.Y.: validation, writing – original draft, and writing – review and editing.

Conflicts of interest disclosure

The authors declare no conflicts of interest.

Research registration unique identifying number (UIN)

Not applicable.

Guarantor

Hritvik Jain.

Data availability statement

Available through the manuscript. No other data were generated.

Provenance and peer review

Not applicable.

Acknowledgements

Assistance with the study: none.

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
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References

1 Health Center for Devises and Radiological Health. Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage. FDA. Published online 3 April 2024. Accessed 16 April 2024. https://www.fda.gov/medical-devices/medical-device-recalls/teleflex-and-arrow-international-recall-arrow-quickflash-radial-artery-and-radial-arteryarterial
2 Lucet JC Bouadma L Zahar JR . Infectious risk associated with arterial catheters compared with central venous catheters. Crit Care Med 2010;38 :1030–1035.20154601
3 Artery Catheter - an overview | ScienceDirect Topics. Accessed 28 May 2024. https://www.sciencedirect.com/topics/nursing-and-health-professions/artery-catheter
4 Wallace MW Solano JJ . Radial Artery Cannulation. StatPearls. StatPearls Publishing; 2024. Accessed 16 April 2024. http://www.ncbi.nlm.nih.gov/books/NBK539796/
5 Imbriaco G Spencer TR Bardin-Spencer A . 10 best practice tips with radial arterial catheterization. J Vasc Access 2024;25 :363–368.35655446
6 Arrow® QuickFlash® Arterial Catheter | US | Teleflex. Accessed 16 April 2024. https://teleflex.com/usa/en/product-areas/vascular-access/arterial-access/quickflash-arterial-catheter/index.html
