Z-2541-2020Class II

TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004...

Name: Z-2541-2020 TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004...
Creator: Abbott
Published: 2020-05-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-05-22 / Terminated / root cause: manufacturing process

FDA source

Abbott began a recall of TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a... on 2020-05-22. FDA classified it as Class II and gives the reason as "High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2541-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-22
Posted: 2020-07-10
Terminated: 2021-02-11
Recalling firm: Abbott Medical
Product: TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.
Product code: OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Reason for recall: High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm began notifying their consignees by letter on 05/22/2020. The notification reported the high rate of reported complaints for loss of contact force information while using the product, the risk to patient, and recommendations to avoid contact force failures.
Quantity in commerce: 84104 devices
Distribution: Worldwide distribution.
Product codes and lots: All batch numbers with an expiration date of April 25, 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2541-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2541-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-09

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)