Arrow Percutaneous Sheath Introducer Kits Recalled for Dilator Tip Damage
Arrow International Inc is recalling specific Percutaneous Sheath Introducer Kits due to dilator tip damage that could cause vessel injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that poses a risk of harm (vessel damage), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Arrow International Inc is recalling 15,424 units of Arrow Percutaneous Sheath Introducer Kits. These medical devices are used to permit venous or arterial access and introduce devices to the central circulation.
The recall was initiated because dilator tip damage was noted during internal inspection. This defect has the potential to result in vessel damage during use.
The affected products were distributed nationwide in the United States and in Canada. Specific product codes and lot numbers are listed in the official recall documentation. Healthcare providers and consumers should stop using the affected kits and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 15,424
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · vessel damage
See all →- HighAneurysm Embolization System Detachment Controller Recalled for Manufacturing Defect
FDA (Devices) · 2022-11-09
- HighOptima Coil System Recalled for Labeling and Packaging Mix-Up
FDA (Devices) · 2022-03-02
- CriticalPenumbra JET 7 Reperfusion Catheter Recalled for Potential Vessel Damage
FDA (Devices) · 2021-01-27
- CriticalPenumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage
FDA (Devices) · 2021-01-27
- CriticalPenumbra JET 7MAX Kits Recalled for Potential Vessel Damage Risk
FDA (Devices) · 2021-01-27
Similar recalls
- HighArrow Percutaneous Sheath Introducer Catheter Recall Due to Adhesive Defect
FDA (Devices) · 2026-04-29
- SevereArrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk
FDA (Devices) · 2017-06-14
- ModerateArrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists
FDA (Devices) · 2018-03-28
- HighArrow International Recalls Percutaneous Sheath Introducer Kits Due to Latex Labeling Error
FDA (Devices) · 2018-08-08
- HighArrow Recalls Percutaneous Sheath Introducer Sets Due to Packaging Damage
FDA (Devices) · 2016-03-16
- SevereArrow Access Kit Recalled Due to Needlestick Injury Risk
FDA (Devices) · 2017-06-14