OSCOR BREEZEWAY 10F S60 — Class II medical device recall Z-0810-2017
Terminated recall by Oscor, Inc., reported 2016-12-28, distributed in CA, FL, MD, MO, NC, NJ, PR, TX. Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sh
| Recall number | Z-0810-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oscor, Inc., Palm Harbor, FL, United States |
| Recall initiated | 2016-10-05 |
| Classified | 2016-12-19 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2019-07-26 |
| Distributed | CA, FL, MD, MO, NC, NJ, PR, TX |
| Countries outside the US | AT, BO, CA, CH, CL, CY, DE, EG, HK, IL, IT, VN |
| Quantity | 255 |
| Model numbers | AB1061FT |
| Expiration dates | 2016-10-06 |
Product
OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Reason for recall
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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-0810-2017. 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.