Device recall: IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for…
Class II FDA enforcement event 69818. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Boston Scientific Corp started this device recall on 20 Nov 2014. The firm address in the FDA record is in San Jose, CA. FDA put the recall in Class II. FDA event 69818 has 1 product record. The first FDA enforcement report date is 17 Dec 2014. The record gives the status Terminated, with the termination date 11 Aug 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.
Recalling firm
Boston Scientific Corp, San Jose, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0580-2015 | IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. | 184 units | Class II | Terminated | 17 Dec 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Nov 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; | Device | Class II | 4 |
| 11 Sep 2015 | One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. | Device | Class II | 1 |
| 3 Feb 2015 | IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620 | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-0580-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 69818. https://recallregister.com/fda/ii/69818/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.
- What quantity of product is in FDA event 69818?
- The FDA record gives this quantity:
184 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.