FDA Device recall Z-1878-2024
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS
- FDA Device
- Class I
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class I recall of Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS by Arrow International, citing teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1878-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-04-29 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Reason
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Identifiers
| code_info | a) REF IAB-05830-LWS, UDI: (01)10801902161892(17)241231(10)18F23A0038, (01)10801902161892(17)250131(10)18F23B0023, (01…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, (01)10801902172843(17)260131(10)18F24B0013, (01)10801902172843(17)260228(10)18F24C0061, (01)10801902172843(17)260228(10)18F24C0109, (01) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Arrow International
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FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC
FDA Device · Class I · 2026-06-24 · Arrow International
All Arrow International recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1878-2024%22
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