Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
Arrow International is recalling intra-aortic balloon catheter kits due to potential inflation failure, catheter damage, and helium loss that could cause serious health consequences.
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: FDA Class I classification indicates reasonable probability of serious adverse health consequences. No deaths or reported illnesses were stated, but the potential for device malfunction in critical cardiac care warrants severity score 4.
Plain-English summary
Arrow International is recalling its FiberOptix Intra-Aortic Balloon Catheter Kit in three models (REF IAB-05830-LWS, REF IAB-05840-LWS, and REF IAB-05850-LWS). Approximately 7,939 affected units were distributed worldwide to healthcare facilities in the United States, Puerto Rico, and numerous international locations.
The devices may fail to inflate completely along their full length, or may exhibit damage or breaks in the central lumen within the balloon. Users may also experience helium loss or blood intrusion into the helium pathway. These defects, when not identified and corrected promptly, could result in serious health consequences.
Healthcare facilities should immediately cease use of affected devices and contact Arrow International for instructions on replacement or return.
The recalled product
- Product
- Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Affected units
- 7,939
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-05830-LWS
- UDI: (01)10801902161892(17)241231(10)18F23A0038
- (01)10801902161892(17)250131(10)18F23B0023
- (01)10801902161892(17)250430(10)18F23D0024
- (01)10801902161892(17)250731(10)18F23H0060
- (01)10801902161892(17)250930(10)18F23J0075
- (01)10801902161892(17)250930(10)18F23K0013
- (01)10801902161892(17)251031(10)18F23L0019
- (01)10801902161892(17)251031(10)18F23L0041
- (01)10801902161892(17)260131(10)18F24B0008
- (01)10801902161892(17)260228(10)18F24C0058
- (01)10801902161892(17)260228(10)18F24C0101
- (01)10801902161892(17)260331(10)18F24D0002
- (01)10801902172843(17)250228(10)18F23C0026
- (01)10801902172843(17)250531(10)18F23F0049
- (01)10801902172843(17)250831(10)18F23J0001
- (01)10801902172843(17)251031(10)18F23L0054
- (01)10801902172843(17)251130(10)18F23M0056
- (01)10801902172843(17)251231(10)18F24A0015
- (01)10801902172843(17)260131(10)18F24A0040
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.
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