EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation… — Class II medical device recall Z-1317-2021
Ongoing recall by EPIX THERAPEUTICS, INC, reported 2021-04-07. It has been identified that the catheter size on the packaging labeling does not correspond to the widest part
| Recall number | Z-1317-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | EPIX THERAPEUTICS, INC, Sunnyvale, CA, United States |
| Recall initiated | 2021-02-22 |
| Classified | 2021-03-29 |
| Reported by FDA | 2021-04-07 |
| Countries outside the US | BE, CA, DE, ES, FR, GB, IT, SI |
| Quantity | 100 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00812499030198 |
| Model numbers | CEDT100S |
Product
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
Reason for recall
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
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-1317-2021. 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.