# FDA recall Z-1879-2024

> **ARROW INTERNATIONAL Inc.** · Class I · device recall initiated 2024-04-29.

## Product

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

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.

## Key facts

- **Recall number:** Z-1879-2024
- **Recalling firm:** ARROW INTERNATIONAL Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-29
- **Report date:** 2024-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1879-2024

## Citation

> AI Analytics. FDA recall Z-1879-2024. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1879-2024. Source: US FDA. Licensed CC0.

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