Z-1322-2021Class II

EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm)...

Name: Z-1322-2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm)...
Creator: Epix Therapeutics, Inc
Published: 2021-02-22
License: https://open.fda.gov/license/

Epix Therapeutics, Inc / initiated 2021-02-22 / Open, Classified / root cause: labeling and UDI

FDA source

EPIX THERAPEUTICS, INC began a recall of EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx... on 2021-02-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1322-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-22
Posted: 2021-03-29
Recalling firm: Epix Therapeutics, Inc
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
Product code: OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On February 22, 2021, Medtronic issued a "Urgent Medical Device Correction" notification via regionally approved methods to consignees who have received affected product. In addition to informing consignees about the recall the firm asked consignees to take the following actions: 1. Review the corrected language applicable to IFU and label as provided in the Appendix below. Until the IFU is updated with the corrected information, the information provided in the Appendix should be used in combination with the existing labeling provided with the DiamondTemp" Catheters. 2. Please share this information with healthcare professionals in your facility that use DiamondTemp" Catheters. Also share this information with any other organization where these devices may have been transferred. 3. Please maintain a copy of this notice in your records. We are committed to patient safety and welcome any questions you may have regarding this communication. Please contact your Medtronic representative with questions.
Quantity in commerce: 13 units
Distribution: Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1322-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1317-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-07	2021-03-29
Z-1318-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-07	2021-03-29
Z-1319-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-07	2021-03-29
Z-1320-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-07	2021-03-29
Z-1321-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-07	2021-03-29
Z-1322-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-07	2021-03-29

Product code OAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)