Z-0169-2023Class II

THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based...

Name: Z-0169-2023 THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based...
Creator: Johnson & Johnson Surgical Vision, Inc.
Published: 2022-09-07
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2022-09-07 / Open, Classified / root cause: manufacturing process

FDA source

Johnson & Johnson Surgical Vision, Inc. began a recall of THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and... on 2022-09-07. FDA classified it as Class II and gives the reason as "Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0169-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-07
Posted: 2022-11-02
Recalling firm: Advanced Medical Optics, Inc.
Product: THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.
Product code: OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Reason for recall: Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 09/07/2022, recall notices were mailed and emailed to customers requesting the following: 1) Ensure that anyone in your facility who needs to be aware of this notification reads the notice carefully. 2) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel. 3) Discard/Destroy the device as per your standard disposal process, ensuring it cannot be used. 4) Complete and return the business response form. Questions can be directed to the recalling firm representative. The following email address was provided: [email protected]
Quantity in commerce: 91
Distribution: Worldwide - US Nationwide distribution in the states of NC, TN, VA, OH, MO, MI, GA, OR, MO, SD, CO, OH, FL, NJ, TX, IL, WI and the countries of CROATIA, GERMANY, HUNGARY.
Product codes and lots: UDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0169-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0169-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-02

Product code OAD

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