CLASS II ONGOING Device recall · Reported 7 Apr 2021 · FDA Enforcement Report
DiamondTemp Unidirectional Large Curve Ablation Catheter recalled
Epix Therapeutics is recalling EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter Size. The recall was initiated on 22 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1318-2021
- FDA event ID
- 87412
- Recalling firm
- Epix Therapeutics, Sunnyvale, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Feb 2021
- FDA classified
- 29 Mar 2021
- Reported
- 7 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 22 Feb 2021 | Recall initiated by company | |
| 29 Mar 2021 | Classified by FDA | +35 days |
| 7 Apr 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
Questions about this recall
Is DiamondTemp Unidirectional Large Curve Ablation Catheter Size, Connector Type: ODU 19 PIN recalled?
Yes. Epix Therapeutics recalled DiamondTemp Unidirectional Large Curve Ablation Catheter Size, Connector Type: ODU 19 PIN on 22 Feb 2021. The recall is Class II and its status is Ongoing. Recall number Z-1318-2021.
Why was it 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.
Which lots are affected?
All Lots
Where was it sold?
Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Epix Therapeutics
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DiamondTemp Unidirectional Small Curve Ablation Catheter recalled | Epix Therapeutics | Sterility | CA |
| Device | CLASS II | DiamondTemp Bidrectional Small Curve Ablation Catheter Size recalled | Epix Therapeutics | Sterility | CA |
| Device | CLASS II | DiamondTemp Unidirectional Ablation Catheter recalled | Epix Therapeutics | Sterility | CA |
| Device | CLASS II | DiamondTemp Unidirectional Ablation Catheter recalled | Epix Therapeutics | Sterility | CA |
| Device | CLASS II | DiamondTemp Bidrectional Large Curve Ablation Catheter Size recalled | Epix Therapeutics | Sterility | CA |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |