Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
Arrow International is recalling its UltraFlex Intra-Aortic Balloon Catheter Kit because of infrequent device malfunction that could lead to serious health consequences. 44,807 units are affected worldwide.
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 with no reported deaths or injuries. Per the rubric, FDA Class I recalls cannot be scored below 4. The potential for serious health consequences in the absence of yet-reported patient harm justifies a score of 4.
Plain-English summary
Arrow International, Inc. is recalling the UltraFlex Intra-Aortic Balloon Catheter Kit (reference numbers IAB-06830-U, IAB-06840-U, and IAB-06850-U). A total of 44,807 units have been distributed worldwide, including throughout the United States and Puerto Rico.
An infrequent condition has been identified in which the intra-aortic balloon may fail to completely inflate along its full length. Alternatively, the device's central lumen may be damaged or broken, or helium may leak from the pathway with blood entering it. These defects could result in serious health consequences if not promptly identified and corrected.
The affected devices have been distributed worldwide to numerous countries. Healthcare providers and patients who have received or used these devices should consult with their physician regarding next steps. Those possessing affected units should contact Arrow International for guidance on replacement or clinical management.
The recalled product
- Product
- Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Affected units
- 44,807
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)
- a) REF IAB-06830-U
- UDI: (01)10801902161939(17)240731(10)18F22H0008
- (01)10801902161939(17)241130(10)18F22M0019
- (01)10801902161939(17)241231(10)18F23A0027
- (01)10801902161939(17)241231(10)18F23A0039
- (01)10801902161939(17)250131(10)18F23B0006
- (01)10801902161939(17)250131(10)18F23B0020
- (01)10801902161939(17)250131(10)18F23B0032
- (01)10801902161939(17)250630(10)18F23G0066
- (01)10801902161939(17)250731(10)18F23H0059
- (01)10801902161939(17)250731(10)18F23H0070
- (01)10801902161939(17)250731(10)18F23H0074
- (01)10801902161939(17)250831(10)18F23J0046
- (01)10801902161939(17)250930(10)18F23K0059
- (01)10801902161939(17)251231(10)18F24A0036
- (01)10801902161939(17)260331(10)18F24D0004
- (01)10801902172898(17)240430(10)18F22E0062
- (01)10801902172898(17)240531(10)18F22F0007
- (01)10801902172898(17)240531(10)18F22F0017
- (01)10801902172898(17)240531(10)18F22F0020
Distribution
Part of a larger recall action
This product is one of 3 recalled by ARROW INTERNATIONAL Inc. 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.
See all 3 products in this recall →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 QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
- SevereArrow ErgoPack central venous catheter recalled for incorrect labeling
FDA (Devices) · 2023-10-11
Same hazard · device malfunction
See all →- ModerateMedtronic NDI Passive Spheres Recalled for Reflective Material Variation
FDA (Devices) · 2026-10-28
- SevereVentec VC+Pro Ventilators Recalled for Potential Cable Disconnection
FDA (Devices) · 2026-10-28
- SevereVentec Ventilator Cable Recall Due to Potential Disconnection
FDA (Devices) · 2026-10-28
- SevereVentec VC+Pro Ventilator Recalled for Potential Connector Disconnection
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim Percutaneous Extensions Recalled for Incompatible Lead Selection
FDA (Devices) · 2026-10-28
Similar recalls
- HighArrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits
FDA (Devices) · 2013-04-17
- ModerateArrow FiberOptix Intra-Aortic Balloon Catheter Kit Recalled for Labeling Error
FDA (Devices) · 2015-03-11
- HighArrow Intra-Aortic Balloon Catheter Kit Recalled for Potential Helium Leak
FDA (Devices) · 2015-03-18
- SevereArrow UltraFlex IAB Recall for Potential Sheath Separation and Bleeding Risk
FDA (Devices) · 2016-03-16
- CriticalArrow UltraFlex IAB Recall: Sheath Separation Risk
FDA (Devices) · 2016-03-16
- SevereArrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Battery Runtime Issues
FDA (Devices) · 2022-12-21