Recall Z-1880-2024— ARROW INTERNATIONAL Inc.
Class I · Ongoing
Class I FDA medical device recall by ARROW INTERNATIONAL Inc., initiated 2024-04-29. It names 2 FDA 510(k) clearances: K000729, K993966. 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..
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-04-29
- Firm location
- Morrisville, NC, United States
510(k) clearances named in this recall
2 on FDA's record- K000729 — ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
- K993966 — 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.