Recall Z-0733-2025 ยท MAV Syringe, Balloon Inflation
Abbott Vascular Inc
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
| Date | Dec 20, 2024 (initiated Nov 6, 2024) |
| Status | Open, Classified |
| Reason | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. |
| Root cause | Component change control |
| Action | On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902 |
| Quantity | 4,975 |
| Distribution | US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) Advanced Cardiovascular Systems, Inc., May 8, 1996 |