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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The source text identifies a risk of serious harm (blood stagnation, clots, or air emboli) due to labeling errors, but does not report any actual injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
EPIX Therapeutics, Inc. is recalling 100 units of the DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size (2.48 mm), Reference CEDT100S. The recall affects all lots of this specific sterile, ethylene oxide-sterilized device.
The recall was initiated because the catheter size listed on the packaging labeling does not correspond to the widest part of the catheter. Additionally, the Instructions for Use (IFU) contain the incorrect diameter for the catheter. These labeling discrepancies could result in blood stagnation, clots, or air emboli during use.
The product was not distributed in the United States. It was distributed in Germany, Spain, France, Belgium, the United Kingdom, Slovenia, Italy, and Canada. Healthcare providers and patients in these regions should verify the physical dimensions of the catheter against the device itself rather than relying solely on the packaging or IFU, and should contact the manufacturer for further guidance.
The recalled product
- 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
- Manufacturer
- EPIX THERAPEUTICS, INC
- Affected units
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by EPIX THERAPEUTICS, INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · EPIX THERAPEUTICS, INC
See all →- HighEPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
FDA (Devices) · 2021-04-07
- HighEPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
FDA (Devices) · 2021-04-07
- HighEPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
FDA (Devices) · 2021-04-07
- HighEPIX Therapeutics DiamondTemp Catheter Recalled for Labeling Errors
FDA (Devices) · 2021-04-07
- HighEPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
FDA (Devices) · 2021-04-07
Same hazard · mis labeling
See all →- High
- ModerateRecall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateMicro Therapeutics Recalls Pipeline Flex Embolization Device Due to Labeling Error
FDA (Devices) · 2026-10-07
- ModerateEpimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling
FDA (Devices) · 2019-07-31
- ModerateEmbolization devices recalled due to incorrect labeling of implant dimensions
FDA (Devices) · 2026-07-29
- ModerateBecton Dickinson Recalls 13 Fr Trialysis Catheters Due to Packaging Error
FDA (Devices) · 2019-11-13
- LowAbbott FIRMap 60mm Catheter Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2015-09-09
- CriticalUniD curve ablation catheters recalled after tip detachment from packaging
FDA (Devices) · 2025-10-22