EPIX Therapeutics recalls DiamondTemp Unidirectional Small Curve Ablation Catheters due to incorrect size labeling on packaging and instructions, which may cause blood stagnation, clots, or air emboli.
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.
EPIX Therapeutics is recalling DiamondTemp Unidirectional Small Curve Ablation Catheters because the packaging and instructions list the wrong size. This could lead to blood clots, air emboli, or blood stagnation during medical procedures.
The catheter's size on the packaging and instructions does not match the actual widest part. This mismatch could cause blood to stagnate, form clots, or air emboli during procedures.
Patients receiving cardiac ablation procedures using this catheter are affected. Medical professionals using the catheter for treatments are at risk of complications.
Check for the DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size (2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198. All lots are affected.
Verify the catheter's size and connector type against the product description provided in the recall notice.
The recall indicates the labeling does not match the actual size, which could cause blood stagnation, clots, or air emboli. It is not safe to use without verification.
The recall does not specify a remedy, so check the product details and contact your healthcare provider for guidance.
Look for the DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size (2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198. All lots are affected.
We’ve drafted a message you can send EPIX Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-1317-2021 — EPIX Therapeutics EPIX Therapeutics Hello, I own a EPIX Therapeutics that is covered by recall Z-1317-2021 from EPIX Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
