Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 15, 2020
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, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abbott recalled TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 076401… - a moderate-severity action.
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 076401… was recalled by Abbott in July 15, 2020. Reason: High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz C…. Check the official notice for the remedy. Verify recall #Z-2541-2020 with the FDA Devices before acting.
The recall
Abbott issued this moderate-severity FDA Devices recall-High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz C….
- Moderate
- severity level
- 84K units
- affected scope
- Class II
- classification
- July 15, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2541-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2541-2020) was formally reported on July 15, 2020, with the manufacturer initiating the action on May 22, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 84104 devices.
The documented reason for this recall is: High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter Distribution data in the federal record shows the product reached: Worldwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
84104 devices
Related Recalls
6
3 from same agency
Product description
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, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.
Reason for recall
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2541-2020 |
| Date reported | July 15, 2020 |
| Date initiated | May 22, 2020 |
| Recalling firm | Abbott |
| Firm location | Plymouth, MN |
| Affected scope | 84104 devices |
| Distribution | Worldwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2541-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.. Recalled by Abbott. Units affected: 84104 devices.
Why was this product recalled? ▼
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2541-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2541-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 15, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.