Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
FDA Recall #Z-1880-2024 — Class I — April 29, 2024
Product Description
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Reason for Recall
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.
Recalling Firm
ARROW INTERNATIONAL Inc. — Morrisville, NC
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
3138 units
Distribution
Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, LB, LU, MA, MN, MK, MX, MY, NL, OM, PA, PF, PH, PL, PT, QA, RE, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UZ, ZA, and UAE.
Code Information
a) REF IAB-05830-U, UDI: (01)10801902172850(17)240531(10)18F22F0023, (01)10801902172850(17)240630(10)18F22G0005, (01)10801902172850(17)240630(10)18F22G0010, (01)10801902172850(17)240731(10)18F22H0033, (01)10801902172850(17)250831(10)18F23J0031, (01)10801902172850(17)250930(10)18F23K0036, (01)10801902172850(17)250930(10)18F23K0042, (01)10801902172850(17)251130(10)18F23M0001, (01)10801902182019(17)250430(10)18F23E0032, (01)10801902182019(17)250831(10)18F23J0002, (01)10801902182019(17)250831(10)18F23J0082, (01)10801902182019(17)250930(10)18F23K0025, (01)10801902182019(17)260331(10)18F24C0131; b) REF IAB-05840-U, UDI: (01)10801902161922(17)240630(10)18F22G0051, (01)10801902161922(17)241231(10)18F23A0002, (01)10801902161922(17)241231(10)18F23A0021, (01)10801902161922(17)241231(10)18F23A0060, (01)10801902161922(17)250731(10)18F23G0068, (01)10801902161922(17)250930(10)18F23K0012, (01)10801902161922(17)251031(10)18F23K0053, (01)10801902161922(17)251031(10)18F23K0063, (01)10801902161922(17)260131(10)18F24B0051, (01)10801902172874(17)240430(10)18F22E0012, (01)10801902172874(17)240630(10)18F22G0011, (01)10801902172874(17)240630(10)18F22G0016, (01)10801902172874(17)250930(10)18F23K0039, (01)10801902172874(17)251031(10)18F23L0010, (01)10801902172874(17)251031(10)18F23L0031, (01)10801902172874(17)251031(10)18F23L0039, (01)10801902172874(17)251130(10)18F23K0008
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated