FDA Enforcement
Class II
Ongoing
EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358
Recall: Z-1319-2021
·
Reported April 7, 2021
Enforcement
- Recall Number
- Z-1319-2021
- Event ID
- 87412
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- EPIX THERAPEUTICS, INC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 7, 2021
- Initiation Date
- February 22, 2021
- Classification Date
- March 29, 2021
- Address
- 945 Stewart Dr Ste 100, Sunnyvale, CA, 94085-3940, United States
Description
EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358
Reason
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.
Code Info
All Lots
Distribution
Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
Quantity
15 units