The Recall Desk

FDA (Devices) recall action 87412

EPIX THERAPEUTICS, INC recalled 6 products on 2021-04-07

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2021-04-07
Critical
0
Units
225

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • HighFDA (Devices)··2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 60 units of DiamondTemp Unidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 18 units of DiamondTemp Bidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 100 units of DiamondTemp Unidirectional Small Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 15 DiamondTemp Bidirectional Small Curve Ablation Catheters because the packaging and instructions for use list incorrect catheter sizes.

    Product
    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 19 DiamondTemp Unidirectional Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-07

    EPIX Therapeutics DiamondTemp Catheter Recalled for Labeling Errors

    EPIX Therapeutics is recalling 13 DiamondTemp Unidirectional Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.

    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
    Category
    Distribution
    0 states