Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1319-2021 — EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358

U.S. FDA — Device Enforcement · United States · 2021-02-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1319-2021
Date of alert
2021-02-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
EPIX THERAPEUTICS, INC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00812499030358
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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