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Lower risk Medical device recall · FDA · Published February 22, 2021

EPIX Therapeutics DiamondTemp Catheter Recall: Incorrect Size Labeling Risk

EPIX Therapeutics recalls DiamondTemp Bidrectional Large Curve Ablation Catheters due to incorrect size labeling on packaging and instructions, which may cause blood stagnation or clots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1320-2021Medical deviceEPIX Therapeutics ›
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Contact the company

Recalling firmEPIX THERAPEUTICS, INC945 Stewart Dr Ste 100 · Sunnyvale, CA 94085-3940
✎ GovInfoNow plain-language explainer

EPIX Therapeutics is recalling DiamondTemp Bidrectional Large Curve Ablation Catheters because the packaging and instructions show the wrong size. This could lead to blood clots or air embolisms during medical procedures. Read more at govinfonow.com/recall/63243-epix-therapeutics-diamondtemp-catheter-recall-incorrect-size-labeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63243-epix-therapeutics-diamondtemp-catheter-recall-incorrect-size-labeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1320-2021

Cite this page

“EPIX Therapeutics DiamondTemp Catheter Recall: Incorrect Size Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63243-epix-therapeutics-diamondtemp-catheter-recall-incorrect-size-labeling-risk. Based on FDA recall #Z-1320-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1320-2021%22&limit=1).

The FDA announced on Feb. 22, 2021, that EPIX Therapeutics is recalling its DiamondTemp Bidirectional Large Curve Ablation Catheter because packaging labeling does not match the catheter size and the Instructions for Use contain an incorrect diameter. This error could result in blood stagnation, clots or air emboli.

How to tell if you have it

  • Brand: EPIX Therapeutics
  • Product: DiamondTemp Bidirectional Large Curve Ablation Catheter
  • Size: 7.5 French Size (2.48 mm)
  • Connector Type: ODU 19 PIN
  • REF: CEDTB400L
  • UDI: 00812499030303
  • Status: All Lots
  • Units affected: 18

The hazard

The catheter size on the packaging labeling does not correspond to the widest part of the catheter, and the Instructions for Use contains the incorrect diameter. According to the FDA, this could result in blood stagnation, clots or air emboli.

Context

GovInfoNow's records show other recent recalls of similar products include Micro Therapeutics Pipeline Flex Embolization Device Recall: Incorrect Diameter Label (2026-06-25) and Micro Therapeutics Pipeline Flex Embolization Device: Incorrect Labeling Risk (2026-06-08). Additional labeling issues were noted in the Micro Therapeutics Pipeline Flex Embolization Device Labeling Error recall on 2026-06-08.

How to tell if you have this one

Look for the DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size (2.48 mm), Connector Type: ODU. All lots are affected.

  • Brand
    EPIX Therapeutics
  • Category
    Medical device
FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
Recall numberProduct, codes & lotsQuantity
Z-1317-2021EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198; All Lots100 units
Z-1318-2021EPIX 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; All Lots60 units
Z-1319-2021EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358; All Lots15 units
Z-1320-2021EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303; All Lots18 units
Z-1321-2021EPIX 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; All Lots19 units
Z-1322-2021EPIX 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; All Lots13 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Verify the catheter's size on the packaging and instructions matches the actual widest part.

How this recall unfolded

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Feb 22, 202112. FDA classified it Class II: Mar 29, 202123. Published in FDA’s Enforcement Report: Apr 7, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1320-2021 (February 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1320-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA