Pacific Xtreme — Class II medical device recall Z-3055-2020
Terminated recall by ev3 Inc., reported 2020-10-07, distributed in AL, AR, AZ, CA, CO, DC, DE, FL…. Labeling discrepancy for the Rated Burst Pressure (RBP) value.
| Recall number | Z-3055-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ev3 Inc., Plymouth, MN, United States |
| Recall initiated | 2020-08-26 |
| Classified | 2020-09-30 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2023-06-09 |
| Distributed | AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV |
| Countries outside the US | CA |
| Quantity | 4,286 devices |
| Reason classes | labeling |
| Lot numbers | 217371272, 217371273, 217451265, 217466571, 217466572, 217466573, 217558443, 217603333, 217603335, 217617124, 217693877, 217728143, 217741797, 217741799, 217790972, 217790974, 217799993, 217799997, 217860448, 217867045, 217867826, 217876552, 217876554, 217876555, 217892596, 217892598, 217914347, 217914351, 217951978, 217951979, 217978889, 217978890, 218033558, 218037674, 218079623, 218153797, 218153799, 218153802, 218170536, 218179770 and 89 more |
| Model numbers | PCU060150090, PCU060150130, PCU060200090, PCU060200130, PCU060250090, PCU060250130, PCU060300090, PCU060300130 |
Product
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Reason for recall
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
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-3055-2020. 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.