Brand Name: RX Accunet Embolic Protection System Common Name: RX… — Class II medical device recall Z-0757-2013
Terminated recall by Abbott Vascular, reported 2013-02-06, distributed nationwide. The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embo
| Recall number | Z-0757-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Vascular, Temecula, CA, United States |
| Recall initiated | 2011-11-30 |
| Classified | 2013-01-31 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2013-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CN, DE, ES, FR, GB, IT, PK, PL, RU, SK, TW, ZA |
| Lot numbers | 1080361, 1080561, 1080861, 1081061, 1081161, 1081661, 1081761, 1081961, 1082261, 1082461, 1082561, 1082661, 1083061, 1090161, 1090261, 1090861, 1091361, 1091561, 1092361, 1092861, 1093061, 1100461, 1100761 |
| Model numbers | 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55, 101649-45 |
Product
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
Reason for recall
The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.
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-0757-2013. 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.