Recall archive / FDA device enforcement
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U — FDA record Z-1880-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- 3138 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1880-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 12, 2024
- Recall initiation date
- Apr 29, 2024
- Center classification date
- Jun 3, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.