Home / Recalls / ARROW INTERNATIONAL Inc. / Z-1879-2024

Z-1879-2024 Class I Ongoing

Recalled by ARROW INTERNATIONAL Inc. — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
June 12, 2024
Initiation Date
April 29, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44,807 units

Product Description

Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-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.

Distribution Pattern

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-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, (01)10801902172898(17)240531(10)18F22F0034, (01)10801902172898(17)240531(10)18F22F0045, (01)10801902172898(17)240531(10)18F22F0057, (01)10801902172898(17)240630(10)18F22G0001, (01)10801902172898(17)240630(10)18F22G0004, (01)10801902172898(17)240630(10)18F22G0007, (01)10801902172898(17)240630(10)18F22G0014, (01)10801902172898(17)240731(10)18F22H0002, (01)10801902172898(17)240731(10)18F22H0024, (01)10801902172898(17)240731(10)18F22H0029, (01)10801902172898(17)240731(10)18F22H0034, (01)10801902172898(17)240831(10)18F22J0009, (01)10801902172898(17)250430(10)18F23D0029, (01)10801902172898(17)250430(10)18F23E0037, (01)10801902172898(17)250430(10)18F23E0038, (01)10801902172898(17)250531(10)18F23E0033, (01)10801902172898(17)250531(10)18F23E0057, (01)10801902172898(17)250531(10)18F23F0023, (01)10801902172898(17)250531(10)18F23F0045, (01)10801902172898(17)250630(10)18F23G0025, (01)10801902172898(17)250630(10)18F23G0026, (01)10801902172898(17)250630(10)18F23G0051, (01)10801902172898(17)250731(10)18F23G0067, (01)10801902172898(17)250731(10)18F23H0009, (01)10801902172898(17)250731(10)18F23H0025, (01)10801902172898(17)250731(10)18F23H0028, (01)10801902172898(17)250731(10)18F23H0069, (01)10801902172898(17)250731(10)18F23H0080, (01)10801902172898(17)250831(10)18F23H0011, (01)10801902172898(17)250831(10)18F23J0004, (01)10801902172898(17)250831(10)18F23J0011, (01)10801902172898(17)250831(10)18F23J0015, (01)10801902172898(17)250831(10)18F23J0053, (01)10801902172898(17)250831(10)18F23J0054, (01)10801902172898(17)250831(10)18F23J0055, (01)10801902172898(17)250930(10)18F23J0079, (01)10801902172898(17)250930(10)18F23K0003, (01)10801902172898(17)250930(10)18F23K0005, (01)10801902172898(17)250930(10)18F23K0009, (01)10801902172898(17)250930(10)18F23K0051, (01)10801902172898(17)250930(10)18F23K0061, (01)10801902172898(17)251031(10)18F23L0040, (01)10801902172898(17)251130(10)18F23M0002, (01)10801902172898(17)251130(10)18F23M0044, (01)10801902172898(17)251130(10)18F23M0049, (01)10801902172898(17)251130(10)18F23M0053, (01)10801902172898(17)251130(10)18F23M0054, (01)10801902172898(17)251231(10)18F23M0055, (01)10801902172898(17)251231(10)18F24A0006, (01)10801902172898(17)251231(10)18F24A0012, (01)10801902172898(17)251231(10)18F24A0013, (01)10801902172898(17)251231(10)18F24A0021, (01)10801902172898(17)260131(10)18F24B0014, (01)10801902172898(17)260228(10)18F24C0004, (01)10801902172898(17)260228(10)18F24C0005, (01)10801902172898(17)260331(10)18F24D0033, (01)10801902172898(17)260331(10)18F24D0036, (01)10801902172898(17)260331(10)18F24D0043, (01)10801902172898(17)260331(10)18F24D0048, (01)10801902172898(17)260331(10)18F24D0086; b) REF IAB-06840-U, UDI: (01)10801902161946(17)240430(10)18F22E0023, (01)10801902161946(17)240531(10)18F22F0009, (01)10801902161946(17)240531(10)18F22F0019, (01)10801902161946(17)240731(10)18F22H0014, (01)10801902161946(17)240731(10)18F22H0028, (01)10801902161946(17)240731(10)18F22H0036, (01)10801902161946(17)241130(10)18F22M0015, (01)10801902161946(17)241231(10)18F23A0019, (01)10801902161946(17)241231(10)18F23A0037, (01)10801902161946(17)241231(10)18F23A0054, (01)10801902161946(17)241231(10)18F23A0055, (01)10801902161946(17)241231(10)18F23A0061, (01)10801902161946(17)250131(10)18F23A0066, (01)10801902161946(17)250131(10)18F23A0067, (01)10801902161946(17)250228(10)18F23A0025, (01)10801902161946(17)250228(10)18F23B0018, (01)10801902161946(17)250331(10)18F23D0018, (01)10801902161946(17)250430(10)18F23E0013, (01)10801902161946(17)250430(10)18F23E0015, (01)10801902161946(17)250630(10)18F23G0002, (01)10801902161946(17)250630(10)18F23G0003, (01)10801902161946(17)250630(10)18F23G0011, (01)10801902161946(17)250731(10)18F23G0063, (01)10801902161946(17)250731(10)18F23H0034, (01)10801902161946(17)250731(10)18F23H0035, (01)10801902161946(17)250731(10)18F23H0038, (01)10801902161946(17)250731(10)18F23H0053, (01)10801902161946(17)250731(10)18F23H0058, (01)10801902161946(17)250731(10)18F23H0071, (01)10801902161946(17)250831(10)18F23J0006, (01)10801902161946(17)250831(10)18F23J0008, (01)10801902161946(17)250831(10)18F23J0014, (01)10801902161946(17)250831(10)18F23J0018, (01)10801902161946(17)250831(10)18F23J0035, (01)10801902161946(17)250831(10)18F23J0042, (01)10801902161946(17)250930(10)18F23K0028, (01)10801902161946(17)260131(10)18F24B0025, (01)10801902161946(17)260131(10)18F24B0026, (01)10801902161946(17)260228(10)18F24C0151, (01)10801902161946(17)260331(10)18F24C0171, (01)10801902161946(17)260331(10)18F24C0177, (01)10801902161946(17)260331(10)18F24C0178, (01)10801902161946(17)260331(10)18F24C0179, (01)10801902161946(17)260331(10)18F24C0180, (01)10801902161946(17)260331(10)18F24C0195, (01)10801902161946(17)260331(10)18F24D0014, (01)10801902161946(17)260331(10)18F24D0017, (01)10801902161946(17)260331(10)18F24D0030, (01)10801902172904(17)240430(10)18F22E0001, (01)10801902172904(17)240430(10)18F22E0009, (01)10801902172904(17)240430(10)18F22E0014, (01)10801902172904(17)240430(10)18F22E0020, (01)10801902172904(17)240430(10)18F22E0036, (01)10801902172904(17)240430(10)18F22E0037, (01)10801902172904(17)240430(10)18F22E0042, (01)10801902172904(17)240430(10)18F22E0046, (01)10801902172904(17)240430(10)18F22E0048, (01)10801902172904(17)240430(10)18F22E0049, (01)10801902172904(17)240430(10)18F22E0061, (01)10801902172904(17)240430(10)18F22E0065, (01)10801902172904(17)240430(10)18F22E0066, (01)10801902172904(17)240531(10)18F22F0002, (01)10801902172904(17)240531(10)18F22F0010, (01)10801902172904(17)240531(10)18F22F0016, (01)10801902172904(17)240531(10)18F22F0021, (01)10801902172904(17)240531(10)18F22F0022, (01)10801902172904(17)240531(10)18F22F0037, (01)10801902172904(17)240531(10)18F22F0043, (01)10801902172904(17)240531(10)18F22F0047, (01)10801902172904(17)240531(10)18F22F0050, (01)10801902172904(17)240531(10)18F22F0051, (01)10801902172904(17)240531(10)18F22F0054, (01)10801902172904(17)240531(10)18F22F0065, (01)10801902172904(17)240531(10)18F22F0066, (01)10801902172904(17)240531(10)18F22F0067, (01)10801902172904(17)240531(10)18F22H0026, (01)10801902172904(17)240630(10)18F22G0067, (01)10801902172904(17)240731(10)18F22H0004, (01)10801902172904(17)240731(10)18F22H0010, (01)10801902172904(17)240731(10)18F22H0030, (01)10801902172904(17)240731(10)18F22H0038, (01)10801902172904(17)240731(10)18F22H0039, (01)10801902172904(17)240930(10)18F22K0004, (01)10801902172904(17)250228(10)18F23C0017, (01)10801902172904(17)250228(10)18F23C0027, (01)10801902172904(17)250228(10)18F23C0044, (01)10801902172904(17)250331(10)18F23D0015, (01)10801902172904(17)250331(10)18R23G0002, (01)10801902172904(17)250430(10)18F23D0027, (01)10801902172904(17)250430(10)18F23D0028, (01)10801902172904(17)250430(10)18F23E0014, (01)10801902172904(17)250430(10)18F23E0028, (01)10801902172904(17)250430(10)18F23E0035, (01)10801902172904(17)250430(10)18F23E0036, (01)10801902172904(17)250430(10)18F23E0050, (01)10801902172904(17)250430(10)18F23E0051, (01)10801902172904(17)250430(10)18F23E0052, (01)10801902172904(17)250531(10)18F23E0055, (01)10801902172904(17)250531(10)18F23F0003, (01)10801902172904(17)250531(10)18F23F0006, (01)10801902172904(17)250531(10)18F23F0007, (01)10801902172904(17)250531(10)18F23F0014, (01)10801902172904(17)250531(10)18F23F0015, (01)10801902172904(17)250531(10)18F23F0024, (01)10801902172904(17)250531(10)18F23F0025, (01)10801902172904(17)250531(10)18F23F0048, (01)10801902172904(17)250531(10)18F23F0052, (01)10801902172904(17)250531(10)18F23F0054, (01)10801902172904(17)250531(10)18F23F0059, (01)10801902172904(17)250630(10)18F23G0005, (01)10801902172904(17)250630(10)18F23G0007, (01)10801902172904(17)250630(10)18F23G0014, (01)10801902172904(17)250630(10)18F23G0028, (01)10801902172904(17)250630(10)18F23G0050, (01)10801902172904(17)250630(10)18F23G0053, (01)10801902172904(17)250731(10)18F23G0064, (01)10801902172904(17)250731(10)18F23G0065, (01)10801902172904(17)250731(10)18F23H0057, (01)10801902172904(17)250731(10)18F23H0075, (01)10801902172904(17)250831(10)18F23H0033, (01)10801902172904(17)250831(10)18F23J0019, (01)10801902172904(17)250831(10)18F23J0041, (01)10801902172904(17)250831(10)18F23J0050, (01)10801902172904(17)250930(10)18F23K0017, (01)10801902172904(17)250930(10)18F23K0018, (01)10801902172904(17)250930(10)18F23K0019, (01)10801902172904(17)250930(10)18F23K0027, (01)10801902172904(17)250930(10)18F23K0040, (01)10801902172904(17)250930(10)18F23K0045, (01)10801902172904(17)250930(10)18F23K0057, (01)10801902172904(17)251031(10)18F23K0060, (01)10801902172904(17)251031(10)18F23L0006, (01)10801902172904(17)251031(10)18F23L0029, (01)10801902172904(17)251031(10)18F23L0030, (01)10801902172904(17)251130(10)18F23M0019, (01)10801902172904(17)251130(10)18F23M0020, (01)10801902172904(17)251130(10)18F23M0037, (01)10801902172904(17)251130(10)18F23M0039, (01)10801902172904(17)251130(10)18F23M0040, (01)10801902172904(17)251130(10)18F23M0041, (01)10801902172904(17)251231(10)18F23M0064, (01)10801902172904(17)251231(10)18F23M0065, (01)10801902172904(17)251231(10)18F24A0002, (01)10801902172904(17)251231(10)18F24A0003, (01)10801902172904(17)251231(10)18F24A0004, (01)10801902172904(17)251231(10)18F24A0005, (01)10801902172904(17)251231(10)18F24A0014, (01)10801902172904(17)251231(10)18F24A0016, (01)10801902172904(17)251231(10)18F24A0022, (01)10801902172904(17)251231(10)18F24A0023, (01)10801902172904(17)251231(10)18F24A0024, (01)10801902172904(17)251231(10)18F24A0038, (01)10801902172904(17)260131(10)18F24B0006, (01)10801902172904(17)260131(10)18F24B0007, (01)10801902172904(17)260131(10)18F24B0023, (01)10801902172904(17)260131(10)18F24B0024, (01)10801902172904(17)260131(10)18F24B0027, (01)10801902172904(17)260131(10)18F24B0028, (01)10801902172904(17)260131(10)18F24B0045, (01)10801902172904(17)260131(10)18F24B0046, (01)10801902172904(17)260131(10)18F24B0047, (01)10801902172904(17)260131(10)18F24B0068, (01)10801902172904(17)260131(10)18F24B0069, (01)10801902172904(17)260228(10)18F24B0067, (01)10801902172904(17)260228(10)18F24B0070, (01)10801902172904(17)260228(10)18F24B0071, (01)10801902172904(17)260228(10)18F24C0006, (01)10801902172904(17)260228(10)18F24C0007, (01)10801902172904(17)260228(10)18F24C0028, (01)10801902172904(17)260228(10)18F24C0029, (01)10801902172904(17)260228(10)18F24C0030, (01)10801902172904(17)260228(10)18F24C0038, (01)10801902172904(17)260228(10)18F24C0092, (01)10801902172904(17)260228(10)18F24C0120, (01)10801902172904(17)260228(10)18F24C0121, (01)10801902172904(17)260228(10)18F24C0141; c) REF IAB-06850-U, UDI: (01)10801902144192(17)240831(10)18F22J0020(13)220916, (01)10801902144192(17)240831(10)18F22J0038(13)220928, (01)10801902144192(17)240831(10)18F22J0043(13)220930, (01)10801902144192(17)240930(10)18F22K0001(13)221003, (01)10801902144192(17)240930(10)18F22K0003(13)221004, (01)10801902144192(17)240930(10)18F22K0006(13)221006, (01)10801902144192(17)240930(10)18F22K0011(13)221007, (01)10801902144192(17)240930(10)18F22K0012(13)221007, (01)10801902144192(17)240930(10)18F22K0013(13)221007, (01)10801902144192(17)241231(10)18F23A0075(13)230131, (01)10801902144192(17)250131(10)18F23B0005(13)230203, (01)10801902144192(17)250131(10)18F23B0010(13)230206, (01)10801902144192(17)250131(10)18F23B0029(13)230220, (01)10801902144192(17)250131(10)18F23B0030(13)230220, (01)10801902144192(17)250228(10)18F23C0007(13)230307, (01)10801902144192(17)250228(10)18F23C0008(13)230307, (01)10801902144192(17)250228(10)18F23C0014(13)230310, (01)10801902144192(17)250228(10)18F23C0015(13)230310, (01)10801902144192(17)250531(10)18F23F0016(13)230609, (01)10801902144192(17)250531(10)18F23F0017(13)230609, (01)10801902144192(17)250831(10)18F23J0043(13)230921, (01)10801902144192(17)250831(10)18F23J0044(13)230923, (01)10801902144192(17)250930(10)18F23J0078(13)231031, (01)10801902144192(17)250930(10)18F23K0015(13)231031, (01)10801902144192(17)250930(10)18F23K0024(13)231014, (01)10801902144192(17)251031(10)18F23L0045(13)231130, (01)10801902144192(17)251130(10)18F23L0052(13)231205, (01)10801902144192(17)251130(10)18F23L0058(13)231205, (01)10801902144192(17)260131(10)18F24B0011(13)240209, (01)10801902144192(17)260131(10)18F24B0012(13)240209, (01)10801902172911(17)250831(10)18F23H0061(13)230911, (01)10801902172911(17)260131(10)18F24B0010(13)240207

Other recalls by ARROW INTERNATIONAL Inc.

  • Z-3299-2024 Class II — Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with (July 26, 2024)
  • Z-1880-2024 Class I — Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) RE (April 29, 2024)
  • Z-1878-2024 Class I — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) (April 29, 2024)
  • Z-1267-2024 Class I — ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbe (February 12, 2024)
  • Z-0001-2024 Class I — Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-l (August 10, 2023)
  • Z-2590-2023 Class II — Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter (August 10, 2023)
  • Z-0003-2024 Class I — Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1 (August 10, 2023)
  • Z-2591-2023 Class II — Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Sty (August 10, 2023)
  • Z-0004-2024 Class I — Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre- (August 10, 2023)
  • Z-0002-2024 Class I — Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CV (August 10, 2023)