# FDA recall Z-1322-2021

> **EPIX THERAPEUTICS, INC** · Class II · device recall initiated 2021-02-22.

## Product

EPIX Therapeutics DiamondTemp Unidirectional Ablation  Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only,  UDI: 00812499030013

## 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.

## Distribution

Product was not distributed in the US.     OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada

## Key facts

- **Recall number:** Z-1322-2021
- **Recalling firm:** EPIX THERAPEUTICS, INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-22
- **Report date:** 2021-04-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2021

## Citation

> AI Analytics. FDA recall Z-1322-2021. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1322-2021. Source: US FDA. Licensed CC0.

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