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TEMPO

CORDIS CORPORATION · Model 451403L5 · UDI-DI 10705032007702

DQO Prescription

510(k) clearances

20,128

Adverse events (445 deaths)

284

Recalls

203

Facilities

Description

CATH TEMPO 4F PIG 110CM 5SH

Recalls

Date	Firm	Reason
2026-04-02	Cook Incorporated	Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio
2026-04-02	Cook Incorporated	Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio
2026-04-02	Cook Incorporated	Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio
2026-03-23	Gentuity, LLC	The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-03	Angiodynamics, Inc.	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
2026-03-03	Angiodynamics, Inc.	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
2026-03-03	Angiodynamics, Inc.	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
2026-03-03	Angiodynamics, Inc.	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
2026-03-03	Angiodynamics, Inc.	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.