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Lower risk Medical device recall · FDA · Published May 22, 2020

Abbott TactiCath Catheter Recall: Loss of Contact Force Information Risk

Abbott recalls TactiCath Quartz Contact Force Ablation Catheters with model PN-004 065 and PN-004 075 due to reported loss of contact force information during use, which may affect heart procedures.

🇺🇸 FDA recall #Z-2541-2020Medical deviceAbbott ›
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Recalling firmAbbott5050 Nathan Ln N · Plymouth, MN 55442-3209
✎ GovInfoNow plain-language explainer

Abbott is recalling two specific models of TactiCath Quartz Contact Force Ablation Catheters because users have reported losing contact force information while using them. This could lead to inaccurate heart procedures if the catheter's contact force isn't properly monitored during ablation treatments. Read more at govinfonow.com/recall/65100-abbott-tacticath-catheter-recall-loss-of-contact-force-information-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65100-abbott-tacticath-catheter-recall-loss-of-contact-force-information-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2541-2020

Cite this page

“Abbott TactiCath Catheter Recall: Loss of Contact Force Information Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65100-abbott-tacticath-catheter-recall-loss-of-contact-force-information-risk. Based on FDA recall #Z-2541-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2541-2020%22&limit=1).

The FDA announced on May 22, 2020, that Abbott voluntarily recalled TactiCath Quartz Contact Force Ablation Catheters due to a high rate of reported complaints regarding the loss of contact force information. The recall involves specific model numbers distributed worldwide with expiration dates of April 25, 2020.

How to tell if you have it

  • TactiCath Quartz Contact Force Ablation Catheter
  • Model Numbers: PN-004 065 (GTIN 07640157990033)
  • Model Numbers: PN-004 075 (GTIN 07640157990040)
  • Expiration date: April 25, 2020

The hazard

The recall was initiated due to a high rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter. The record does not report specific incidents or injuries associated with this hazard.

Context

GovInfoNow's records show Abbott has 12 other recalls on record since April 5, 2018. Recent brand recalls include a September 10, 2025 recall for tip detachment events and a March 17, 2025 recall for the Amplatzer TorqVue LP Delivery System involving potential blood loss or air embolism. Other recent recalls of similar products include the Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray (November 6, 2025), Medical Action Industries Pack Cath BHH (March 17, 2026), and Medline Medical Procedure Kits (May 4, 2026).

How to tell if you have this one

Check for model numbers PN-004 065 (GTIN 07640157990033) or PN-004 075 (GTIN 07640157990040) on the catheter packaging or label. The product was sold with an expiration date of April 25, 2020.

  • Brand
    Abbott
  • Product
    TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Model Number

    Look for model numbers PN-004 065 or PN-004 075 on the catheter packaging or label.

How this recall unfolded

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: May 22, 202012. FDA classified it Class II: Jul 9, 202023. Published in FDA’s Enforcement Report: Jul 15, 202034. FDA terminated the recall: Feb 11, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2541-2020 (May 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2541-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA