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Ablacon™ Mapping Catheter

Ablacon Inc. · Model AB-0003-50 · UDI-DI 00860457001544

MTD Prescription

510(k) clearances

1,862

Adverse events (30 deaths)

Recalls

Facilities

Description

The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardial surfaces of the heart. These signals may be used for analysis with mapping systems. The Ablacath™ Mapping Catheter may also be used to deliver externally generated pacing stimuli.

Recalls

Date	Firm	Reason
2022-04-28	Abbott	Incorrect product labeling.
2020-04-22	BIOSENSE WEBSTER	Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
2017-05-17	Biosense Webster, Inc.	Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
2017-05-17	Biosense Webster, Inc.	Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
2016-04-14	Biosense Webster, Inc.	Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to p
2016-04-14	Biosense Webster, Inc.	Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to p
2015-08-12	Abbott Electrophysiology	The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for th
2014-02-20	Biosense Webster, Inc.	Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the reca
2005-02-14	Boston Scientific	The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.

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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.