AccessPLUS Large Bore Hemostasis Valves — Class II medical device recall Z-0904-2022
Ongoing recall by Merit Medical Systems, Inc., reported 2022-04-20, distributed in AK, AL, AR, AZ, CA, CO, DC, DE…. A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rot
| Recall number | Z-0904-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2022-03-01 |
| Classified | 2022-04-11 |
| Reported by FDA | 2022-04-20 |
| Distributed | AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AT, BE, CA, CH, CO, CZ, DE, ES, FR, GB, GR, HN, IE, IT, JP, KR, LU, NL, PL |
| Quantity | 58,963 |
| Lot numbers | 580758001/P2073001, 580774001/I2219768, H2265127, H2271477, H2272368, H2281405, H2281419, H2283595, H2287442, H2287443, H2288909, H2295915, H2298629, H2298630, H2299830, H2302500, H2302503, H2302505, H2305053, H2305054, H2305137, H2309362, H2309793, H2309893, H2311255, H2319811, I2176727, I2259668, I2259669, I2279930, I2279933, I2289614, I2289615, I2289616, IN8152/C/H2292361, IN8152/H2305053, K04-01197/H2296388, K05T-01863/T2313699, K09-09102B/H2308279, K09-10388A/H2285501 and 21 more |
| Model numbers | 580758001, 580758001/P2073001, 580774001, IN8152, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-01551, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, K12-YP064A, K12-YP114, K12-YP115 and 4 more |
Product
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
Reason for recall
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0904-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.