Z-1880-2024Class I

Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U

Name: Z-1880-2024 Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Creator: ARROW INTERNATIONAL Inc.
Published: 2024-04-29
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2024-04-29 / Open, Classified / root cause: manufacturing process

FDA source

ARROW INTERNATIONAL Inc. began a recall of Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U on 2024-04-29. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1880-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-04-29
Posted: 2024-06-03
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1880-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1878-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-03
Z-1879-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-03
Z-1880-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-03

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)