FDA Device Recall Z-1878-2024

ARROW INTERNATIONAL Inc. · Morrisville, NC

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

Lot / serial / GTIN: 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)10801902172843(17)260228(10)18F24C0110, (01)10801902172843(17)260331(10)18F24C0172, (01)10801902172843(17)260331(10)18F24C0173, (01)10801902172843(17)46112(10)18F24C0088, (01)10801902172843(17)46112(10)18F24C0089, (01)10801902172843(17)46112(10)18F24C0174, (01)10801902172843(17)46112(10)18F24C0175, (01)10801902172843(17)46112(10)18F24C0176, (01)10801902172843(17)46112(10)18F24C0185; b) REF IAB-05840-LWS, UDI: (01)10801902167733(17)240531(10)18F22F0072, (01)10801902167733(17)240630(10)18F22G0021, (01)10801902167733(17)240630(10)18F22G0031, (01)10801902167733(17)240630(10)18F22G0046, (01)10801902167733(17)240731(10)18F22H0009, (01)10801902167733(17)240731(10)18F22H0023, (01)10801902167733(17)240731(10)18F22H0058, (01)10801902167733(17)240930(10)18F22K0015, (01)10801902167733(17)241130(10)18F22M0017, (01)10801902167733(17)241130(10)18F22M0018, (01)10801902167733(17)241231(10)18F23A0004, (01)10801902167733(17)241231(10)18F23A0005, (01)10801902167733(17)241231(10)18F23A0018, (01)10801902167733(17)241231(10)18F23A0026, (01)10801902167733(17)250131(10)18F23B0008, (01)10801902167733(17)250131(10)18F23B0016, (01)10801902167733(17)250531(10)18F23E0054, (01)10801902167733(17)250630(10)18F23G0017, (01)10801902167733(17)250731(10)18F23H0029, (01)10801902167733(17)250731(10)18F23H0064, (01)10801902167733(17)251031(10)18F23L0009, (01)10801902167733(17)251031(10)18F23L0028, (01)10801902167733(17)251231(10)18F23M0068, (01)10801902167733(17)251231(10)18F24A0030, (01)10801902167733(17)251231(10)18F24A0039, (01)10801902167733(17)260131(10)18F24B0015, (01)10801902167733(17)260131(10)18F24B0031, (01)10801902167733(17)260228(10)18F24C0008, (01)10801902167733(17)260228(10)18F24C0069, (01)10801902167733(17)260228(10)18F24C0071, (01)10801902167733(17)260228(10)18F24C0072, (01)10801902167733(17)260228(10)18F24C0075, (01)10801902167733(17)260228(10)18F24C0076, (01)10801902167733(17)260228(10)18F24C0077, (01)10801902167733(17)260228(10)18F24C0078, (01)10801902167733(17)260228(10)18F24C0079, (01)10801902167733(17)260228(10)18F24C0080, (01)10801902167733(17)260228(10)18F24C0081, (01)10801902167733(17)260331(10)18F24C0083, (01)10801902167733(17)260331(10)18F24C0186, (01)10801902167733(17)260331(10)18F24C0187, (01)10801902167733(17)260331(10)18F24C0188, (01)10801902167733(17)260331(10)18F24C0193, (01)10801902167733(17)260331(10)18F24D0020, (01)10801902167733(17)260331(10)18F24D0021, (01)10801902167733(17)260331(10)18F24D0022, (01)10801902167733(17)260331(10)18F24D0031, (01)10801902167733(17)260331(10)18F24D0032, (01)10801902167733(17)260331(10)18F24D0037, (01)10801902167733(17)260331(10)18F24D0038, (01)10801902167733(17)260331(10)18F24D0039, (01)10801902167733(17)260331(10)18F24D0042, (01)10801902167733(17)260331(10)18F24D0044, (01)10801902167733(17)260331(10)18F24D0045, (01)10801902167733(17)260331(10)18F24D0049, (01)10801902167733(17)260331(10)18F24D0050, (01)10801902167733(17)260331(10)18F24D0051, (01)10801902167733(17)260331(10)18F24D0054, (01)10801902167733(17)260331(10)18F24D0055, (01)10801902167733(17)260331(10)18F24D0072, (01)10801902167733(17)260331(10)18F24D0087, (01)10801902167733(17)260331(10)18F24D0088, (01)10801902167733(17)260331(10)18F24D0089, (01)10801902167733(17)260331(10)18F24D0090, (01)10801902167733(17)260331(10)18F24D0091, (01)10801902167733(17)260331(10)18F24D0092, (01)10801902172867(17)240430(10)18F22E0008, (01)10801902172867(17)240430(10)18F22E0029, (01)10801902172867(17)240531(10)18F22F0006, (01)10801902172867(17)240531(10)18F22F0018, (01)10801902172867(17)240531(10)18F22F0039, (01)10801902172867(17)240630(10)18F22G0002, (01)10801902172867(17)240630(10)18F22G0003, (01)10801902172867(17)240630(10)18F22G0019, (01)10801902172867(17)240630(10)18F22G0059, (01)10801902172867(17)240731(10)18F22H0035, (01)10801902172867(17)240831(10)18F22J0025, (01)10801902172867(17)240930(10)18F22K0016, (01)10801902172867(17)250430(10)18F23E0020, (01)10801902172867(17)250531(10)18F23F0002, (01)10801902172867(17)250531(10)18F23F0026, (01)10801902172867(17)250630(10)18F23G0008, (01)10801902172867(17)250731(10)18F23G0057, (01)10801902172867(17)250731(10)18F23H0013, (01)10801902172867(17)250731(10)18F23H0055, (01)10801902172867(17)250831(10)18F23J0003, (01)10801902172867(17)250831(10)18F23J0037, (01)10801902172867(17)250831(10)18F23J0072, (01)10801902172867(17)250930(10)18F23J0073, (01)10801902172867(17)251031(10)18F23K0054, (01)10801902172867(17)251130(10)18F23L0055, (01)10801902172867(17)251130(10)18F23M0043, (01)10801902172867(17)251231(10)18F24A0025, (01)10801902172867(17)251231(10)18F24A0031, (01)10801902172867(17)260131(10)18F24B0005, (01)10801902172867(17)260131(10)18F24B0048, (01)10801902172867(17)260131(10)18F24B0052, (01)10801902172867(17)260228(10)18F24B0078, (01)10801902172867(17)260228(10)18F24C0036, (01)10801902172867(17)260228(10)18F24C0064, (01)10801902172867(17)260228(10)18F24C0065, (01)10801902172867(17)260228(10)18F24C0067, (01)10801902172867(17)260228(10)18F24C0068, (01)10801902172867(17)260228(10)18F24C0105; c) REF IAB-05850-LWS, UDI: (01)10801902167726(17)240831(10)18F22J0037(13)220927, (01)10801902167726(17)240831(10)18F22J0040(13)220929, (01)10801902167726(17)240930(10)18F22K0044(13)221021, (01)10801902167726(17)240930(10)18F22K0045(13)221021, (01)10801902167726(17)241031(10)18F22K0056(13)221028, (01)10801902167726(17)241031(10)18F22L0012(13)221104, (01)10801902167726(17)250930(10)18F23K0006(13)231031, (01)10801902167726(17)260131(10)18F24B0049(13)240227, (01)10801902167726(17)260228(10)18F24B0075(13)240301, (01)10801902172881(17)250930(10)18F23K0038(13)231028, (01)10801902172881(17)260228(10)18F24C0031(13)240316, (01)10801902172881(17)260228(10)18F24C0032(13)240331, (01)10801902172881(17)260228(10)18F24C0033(13)240315, (01)10801902172881(17)260228(10)18F24C0034(13)240315

Quantity: 7939 units

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.

Recall record

Recall number: Z-1878-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
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.
Recall initiated: 2024-04-29
Classified by FDA Center: 2024-06-03
FDA published: 2024-06-12
Recalling firm: ARROW INTERNATIONAL Inc.
Firm location: Morrisville, NC

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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