Embolectomy Catheters — Class II medical device recall Z-2446-2012
Terminated recall by Applied Medical Resources Corp, reported 2012-10-03, distributed nationwide. Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential
| Recall number | Z-2446-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2012-08-09 |
| Classified | 2012-09-25 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2013-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, DE, EC, EE, ES, FR, GB, HK, IE, IL, IT, KR, MY, NL, NZ, PK, PL, PT, QA, RS, SA, TW, ZA |
| Quantity | 40,238 units |
| Reason classes | specification failure |
| Lot numbers | 1154435, 1154446, 1154478, 1155214, 1155230, 1155427, 1155428, 1155648, 1155854, 1155855, 1155856, 1156256, 1156271, 1156522, 1156935, 1156936, 1157052, 1157053, 1157054, 1157060, 1158624, 1159414, 1159725, 1160007, 1160221, 1160222, 1160223, 1160310, 1161471, 1161472, 1161791, 1161792, 1161793, 1161997, 1161998, 1162689, 1162866, 1162945, 1162967, 1163215 and 110 more |
| Model numbers | 1154435, 1154446, 1154478, 1155214, 1155230, 1155427, 1155428, 1155648, 1155854, 1155855, 1155856, 1156256, 1156271, 1156522, 1156935, 1156936, 1157052, 1157053, 1157054, 1157060, 1158624, 1159414, 1159725, 1160007, 1160221 and 129 more |
Product
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.
Reason for recall
Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
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-2446-2012. 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.