Recall Z-1878-2024 ยท DSP System, Balloon, Intra-Aortic And Control
ARROW INTERNATIONAL Inc.
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
| Date | Jun 3, 2024 (initiated Apr 29, 2024) |
| Status | Open, Classified |
| 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. |
| 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 |
| Quantity | 7939 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Arrow International, Inc., Apr 9, 2020 |