Device recall: EMBLEM S-ICD Model A209
Class I FDA enforcement event 86902. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Electrical overstress may lead to device malfunction.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Boston Scientific Corporation started this device recall on 2 Dec 2020. The firm address in the FDA record is in Saint Paul, MN. FDA put the recall in Class I. FDA event 86902 has 2 product records. The first FDA enforcement report date is 17 Feb 2021. The record gives the status Terminated, with the termination date 23 Jun 2022.
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.
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
Recalling firm
Boston Scientific Corporation, Saint Paul, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0950-2021 | EMBLEM S-ICD Model A209 | 1953 units | Class I | Terminated | 17 Feb 2021 |
| Z-0951-2021 | EMBLEM MRI S-ICD Model A219 | 872 units | Class I | Terminated | 17 Feb 2021 |
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 I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class I
- 4%
- Product records in this event
- 2Median of the firm: 2
- Events of the firm on the register
- 162
Other events of the firm
Official channels
- FDA enforcement report Z-0950-2021The 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 86902. https://recallregister.com/fda/i/86902/. 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:
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
- What quantity of product is in FDA event 86902?
- The event has 2 product records. The first record gives this quantity:
1953 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 4% of the 916 device events that started in 2020 are in Class I.