Python Embolectomy Catheters — Class I medical device recall Z-1846-2020
Terminated recall by Applied Medical Resources Corp, reported 2020-05-13, distributed nationwide. The firm has received reports of tip separation during usage of the catheters, which may expose patients to un
| Recall number | Z-1846-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2019-10-24 |
| Classified | 2020-05-07 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2023-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CZ, DE, ES, FR, GB, HK, IE, IL, IT, JP, NL, PL, SA, TW, ZA |
| Quantity | 28,799 catheters |
| UPC / GTIN / UDI-DI | 00607915113407, 00607915113414, 00607915113421, 00607915113438, 00607915113445, 00607915113452, 00607915113476, 00607915113483 |
| Lot numbers | 1252636, 1255539, 1256874, 1257416, 1259463, 1259464, 1260019, 1261855, 1262756, 1263092, 1263093, 1263484, 1265630, 1266989, 1267854, 1268170, 1268371, 1268372, 1268451, 1268688, 1269004, 1269005, 1273184, 1273374, 1274343, 1276314, 1276315, 1276316, 1276317, 1278603, 1281314, 1281315, 1281783, 1281784, 1281786, 1281787, 1283399, 1283401, 1283650, 1283770 and 96 more |
| Model numbers | A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09 |
Product
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483
Reason for recall
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
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-1846-2020. 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.