Z-1213-2022Class II

FIRMap" Catheter, 60mm Basket

Name: Z-1213-2022 FIRMap" Catheter, 60mm Basket
Creator: Abbott
Published: 2022-04-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-04-28 / Terminated / root cause: manufacturing process

FDA source

Abbott began a recall of FIRMap" Catheter, 60mm Basket on 2022-04-28. FDA classified it as Class II and gives the reason as "Incorrect product labeling". 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-1213-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-28
Posted: 2022-06-01
Terminated: 2024-06-18
Recalling firm: Abbott Medical
Product: FIRMap" Catheter, 60mm Basket
Product code: MTD Catheter, Intracardiac Mapping, High-Density Array
Reason for recall: Incorrect product labeling.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm sent out a "MEDICAL DEVICE RECALL" notification letter dated 04/28/2022 via hand delivery to the US customers. OUS consignee notification is via hand delivery. A copy of the English version of the OUS letter is attached and this letter was translated into the appropriate languages for delivery. The letter instructs the consignee to stop using the remaining inventory, complete and return the acknowledgement form by email: [email protected], and return all unused devices. Should you have questions about this issue, please contact your local Abbott Representative or Abbot Support at 1-888-655-3500 (Option 2) (U.S.), 8:30 a.m. - 5:30 p.m. Central Time Monday through Friday.
Quantity in commerce: 40 units
Distribution: US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Product codes and lots: Model Number: AR064060; UDI Number: ( 01) 0 0810591 02002 4 ( 17) 020531 ( 00) 1 2345678 95; Batch Numbers: 2158303 (Exp. Date: 30 NOV 2022), 2159876 (Exp. Date: 31 JAN 2023), 2156510 (Exp. Date: 30 SEP 2022), 2162996 (Exp. Date: 31 MAR 2023), 2159875 (Exp. Date: 30 NOV 2022), and 2159877 ( Exp. Date: 30 NOV 2022).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1213-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1213-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-08	2022-06-01

Product code MTD

K142182Class IIFrimap Adapter Connector (Mac)Topera, Inc. / cleared 2014-09-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)