ARROW recallZ-1878-2024 · ARROW INTERNATIONAL Inc. · initiated Apr 29, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ARROW INTERNATIONAL Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Teleflex/ARROW INTERNATIONAL issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 04/29/2024 via FedEx 2-day mail. 1. Prior to use, ensure that a backup IAB catheter is available. 2. Prior to insertion, inspect all in-scope IAB catheters for signs of an over-twisted balloon wrap or bent balloon shaft. Do not insert catheters suspected of manifesting an over-twisted wrap. 3. Insert all in-scope IAB catheters under fluoroscopic guidance. Use fluoroscopy to assess complete balloon inflation. Span the full length of the balloon, include several cycles of inflation/deflation. Keep fluoroscopy available for up to 3 minutes after one-to-one cyclic counterpulsation begins, or until full balloon inflation is confirmed. 4. Be vigilant in responding to pump alarms consistent with the Instructions For Use and Users Guide (IFU). . when an Arrow AC3 or Autocat-2 pump is used, a high-pressure or high baseline alarm may sound. These red-condition alarms require immediate attention per the IFU. The alarms provide a troubleshooting algorithm that includes incomplete IAB inflation. . when a Getinge CardioSave pump is used, an IAB catheter restriction alarm may sound. . A pump alarm indicating helium leakage (helium loss or gas loss) may signal the IAB catheter is not performing as expected. . Real-time telephone support for Arrow IABPs and IAB catheters is available. 5. Be vigilant in responding to bedside indicators that an IAB catheter is not performing as expected, including Blood in helium pathway and Lower than expected diastolic pressure augmentation. Immediate actions If an IAB catheter is suspected of having this issue: remove and replace the catheter using steps outlined in the IFU. A replacement balloon catheter may be inserted contralaterally or ipsilaterally as determined by the responsible physician after considering the patient s individual femoral access options and relevant clinical features.
Recall details
- Recall number
- Z-1878-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 29, 2024
- Posted by the FDA
- Jun 3, 2024
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- 7939 units
- Product code
- DSP
- FDA submissions
- K200634
- 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.
Product description
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Code information (models, lots, serial numbers)
Show the full code information (7k characters)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARROW IPN915319Teleflex Incorporated · System, balloon, intra-aortic and control1 recall17 reports
- ARROW IPN916138Teleflex Incorporated · System, balloon, intra-aortic and control1 recall8 reports
- ARROW IPN915317Teleflex Incorporated · System, balloon, intra-aortic and control1 recall4 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K200634 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARROW IPN929209Teleflex Incorporated · System, balloon, intra-aortic and control121 reports
- ARROW IPN929210Teleflex Incorporated · System, balloon, intra-aortic and control57 reports
- ARROW IPN929208Teleflex Incorporated · System, balloon, intra-aortic and control23 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94526).
- Z-1879-2024 · Open, ClassifiedArrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
- Z-1880-2024 · Open, ClassifiedArrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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