Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 11, 2015
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is no
Reports of formation of char adherent to the proximal part of the distal tip electrodes
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Boston Scientific Corp recalled IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004E… — a critical-severity action.
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004E… was recalled by Boston Scientific Corp in March 11, 2015. Reason: Reports of formation of char adherent to the proximal part of the distal tip electrodes. Check the official notice for the remedy. Verify recall #Z-1209-2015 with the FDA Devices before acting.
The recall
Boston Scientific Corp issued this critical-severity FDA Devices recall — Reports of formation of char adherent to the proximal part of the distal tip electrodes.
- Critical
- severity level
- 14 units
- affected scope
- Class I
- classification
- March 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1209-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1209-2015) was formally reported on March 11, 2015, with the manufacturer initiating the action on February 3, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Boston Scientific Corp is listed as the recalling firm, operating out of San Jose, CA. Federal records list the affected scope as 14 units.
The documented reason for this recall is: Reports of formation of char adherent to the proximal part of the distal tip electrodes Distribution data in the federal record shows the product reached: Distributed in Germany, Great Britain, and the Netherlands.. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
14 units
Related Recalls
6
6 from same agency
Product description
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.
Reason for recall
Reports of formation of char adherent to the proximal part of the distal tip electrodes
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1209-2015 |
| Date reported | March 11, 2015 |
| Date initiated | February 3, 2015 |
| Recalling firm | Boston Scientific Corp |
| Firm location | San Jose, CA |
| Affected scope | 14 units |
| Distribution | Distributed in Germany, Great Britain, and the Netherlands. |
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-1209-2015) 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.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. 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? ▼
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.. Recalled by Boston Scientific Corp. Units affected: 14 units.
Why was this product recalled? ▼
Reports of formation of char adherent to the proximal part of the distal tip electrodes
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2015. Severity: Critical. Recall number: Z-1209-2015.
Where was the recalled product distributed? ▼
Distribution: Distributed in Germany, Great Britain, and the Netherlands..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1209-2015) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 11, 2015.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.