Arrow-Clark VectorFlow Hemodialysis Catheters with Defective Sheath Introducer
Arrow International is recalling Arrow-Clark VectorFlow hemodialysis catheters due to a supplier defect in the sheath introducer that may fail to split properly, potentially causing withdrawal resistance, prolonged procedures, pain, bleeding, and tissue injury.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device. Although no reported injuries or hospitalizations are explicitly stated in the source text, Class I recalls by definition involve risks of serious injury or death, and the hazard description (bleeding, hematoma, tissue injury, vessel wall injury) establishes significant injury risk. Per the rubric, FDA Class I recalls must not go below a score of 4.
Plain-English summary
Arrow International, LLC is recalling Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheters, Arrow-Clark VectorFlow Antegrade Hemodialysis Catheters with Arrow Simplicity Micro-Introducer, Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheters, and Arrow-Clark VectorFlow Retrograde Hemodialysis Catheters with Arrow Simplicity Micro-Introducer. These products were distributed worldwide, including nationwide in the United States.
The recall affects hemodialysis kits and sets containing a 16F dual-valved splittable sheath introducer that was subject to a supplier recall. The sheath introducer may not split as intended during use.
If the sheath introducer fails to split properly, patients may experience withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, and vessel wall injury. A total of 92,827 units are affected by this recall.
Patients and healthcare providers using these catheters should contact Arrow International, LLC for instructions regarding the affected products. The FDA recall number is Z-2157-2026.
The recalled product
- Product
- Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI…
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 92,827
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lots: ACS-15192-VFI/ 10801902126709/33F23G0040
- 33F25C0689
- ACS-15232-VFI/10801902126723/33F23G0045
- 33F25C0678
- ACS-15272-VFI/ 10801902126747/33F24G0638
- CS-15192-VFI/10801902127188
- 10801902193572/33F23E0579
- 33F23G0042
- 33F23K0170
- 33F23L0933
- 33F24E0271
- 33F24G0166
- 33F24J0086
- 33F24L0064
- 33F24M0224
- 33F25C0652
- 33F25D0052
- 33F25D0700
- 33F25E1081
- 33F25F0015
Distribution
Part of a larger recall action
This product is one of 4 recalled by ARROW INTERNATIONAL, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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