ARROW INTERNATIONAL Inc.: Device Recall
Recall #Z-1878-2024 · 04/29/2024
Recall Details
- Recall Number
- Z-1878-2024
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- ARROW INTERNATIONAL Inc.
- Status
- Ongoing
- Date Initiated
- 04/29/2024
- Location
- Morrisville, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7939 units
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.
Product Description
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
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.
Other Recalls by ARROW INTERNATIONAL Inc.
- Class II: Risk 07/26/2024
- Class I: Dangerous 04/29/2024
- Class I: Dangerous 04/29/2024