The Recall Desk
HighFDA (Devices)·Z-0169-2023·Announced 2022-11-09

Cardiac Navigation Catheter Recalled for Cellulose Fiber Contamination

Johnson & Johnson is recalling 91 THERMOCOOL SMARTTOUCH SF cardiac catheters nationwide due to manufacturing defects introducing cellulose fibers into the irrigation system. The contamination may prevent proper flushing, reduce cooling capability, or cause clotting complications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall involving potential harm to patients in critical cardiac procedures. The contamination could prevent effective ablation delivery or cause thrombogenic complications. However, no illnesses or injuries have been reported and the hazard remains theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High (3) classification.

Plain-English summary

Johnson & Johnson Surgical Vision, Inc. is recalling the THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter (model D-1348-05-S) due to manufacturing errors that introduced cellulose fibers into the catheter's irrigation pathway. The recall affects 91 units distributed nationwide across multiple U.S. states and internationally.

The contamination may result in three failure modes: the catheter may fail initial flushing inspection and be unusable; irrigation may become insufficient, causing the catheter tip to overheat and limiting the device's ability to deliver cardiac ablation therapy; or cellulose particles may be flushed through the catheter and cause thrombogenic or toxic effects in the patient.

This device is used by cardiac electrophysiology specialists for mapping and ablation procedures. Healthcare facilities that received affected units should immediately quarantine them, verify the lot numbers against the recall notice, and contact Johnson & Johnson for replacement units. Patients who have already undergone procedures with this catheter should be monitored according to standard post-procedure protocols.

The recalled product

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.
Manufacturer
Johnson & Johnson Surgical Vision, Inc.
Category
Medical Device — Cardiac Electrophysiology
Hazard
  • contamination-cellulose
  • insufficient-irrigation
  • thrombogenic-risk
  • device-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • UDI-DI/Lots: 10846835010183/30779056L
  • 30808001L
  • 30814782L
  • 30814783L
  • 30779172L

Distribution

Distributed nationwide across the United States.

Related recalls

Same category