Home / Recalls / EPIX THERAPEUTICS, INC / Z-1317-2021

Z-1317-2021 Class II Ongoing

Recalled by EPIX THERAPEUTICS, INC — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
April 7, 2021
Initiation Date
February 22, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 units

Product Description

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.

Distribution Pattern

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

Code Information

All Lots

Other recalls by EPIX THERAPEUTICS, INC

  • Z-1320-2021 Class II — EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 F (February 22, 2021)
  • Z-1318-2021 Class II — EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7. (February 22, 2021)
  • Z-1322-2021 Class II — EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7. (February 22, 2021)
  • Z-1319-2021 Class II — EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 F (February 22, 2021)
  • Z-1321-2021 Class II — EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7 (February 22, 2021)