Abbott Recalls TactiCath Quartz Contact Force Ablation Catheters Due to Data Loss
Abbott is recalling TactiCath Quartz Contact Force Ablation Catheters because they may lose contact force information during use.
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: The recall is classified as FDA Class II. The hazard involves the loss of critical contact force data during a medical procedure, which poses a risk of harm to patients, but the source does not report specific injuries or fatalities.
Plain-English summary
Abbott is recalling 84,104 units of the TactiCath Quartz Contact Force Ablation Catheter, specifically model numbers PN-004 065 and PN-004 075. The recall affects all batch numbers with an expiration date of April 25, 2020. These devices were distributed worldwide.
The recall is being conducted due to a high rate of reported complaints regarding the loss of contact force information while using the catheter. The TactiCath Quartz is a multi-electrode irrigated catheter with a deflectable tip designed for electrophysiological mapping of the heart and delivering radiofrequency current for ablation when connected to an RF generator.
The U.S. Food and Drug Administration has classified this recall as Class II. Healthcare providers and facilities should stop using the affected devices and contact Abbott for further instructions on the recall process.
The recalled product
- 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,
- Manufacturer
- Abbott
- Affected units
- 84,104
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 (2)
- All batch numbers with an expiration date of April 25
- 2020
Distribution
Distribution scope not specified by the agency.
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