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Definitions of Field Safety Corrective Actions, Recalls and other compliance terms may be different between countries and areas, refer to our + 3,000 Compliance Definitions Navigation Panel to extract terms in multiple countries. Our market database covers the 21 main market countries, based on the information that authorities made available to public.

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24-06-2019

There have been a total of 5,557 Field Safety Corrective Actions (FSCAs) published so far this year 2019 until 15th June, in 21 Countries, and 744 Manufacturers involved. The following represents some analytics and insights from the information made available by Authorities, and then structured, normalized, categorized, and cleaned by the MedBoard data team. If you wish to obtain more granular data specific to your needs and interests, or in-depth data about rationales, related products, competition, or other, or to get the full report, please get in touch with us.

*IMPORTANT: Please note these are aggregated figures based on the information published by Authorities. The level of transparency and information may vary depending on the country, same as the definition of the action, take this report as indicative. For example, some countries would disclose all Corrective Actions, but others only Recalls. The FSCA term used covers all range of Corrective Actions published by each Authority. For more detailed reports on specific cases, or only about market withdrawals, get in touch with us.

Relevant Insights: 

  • Top Medical Area so far this year in those 21 countries is In Vitro Diagnostic Devices, with 1251 FSCAs, followed by Cardiology, Radiology, Hospital Equipment, and Orthopaedics.
  • IVDs FSCAs rank the highest in 3 regions: Europe, ASPAC, LATAM, but not in North America, where Cardiology and Orthopaedics are higher than IVD.
  • There is a marked differentiation between two groups in terms of number of FSCAs, the consistent higher areas: IVDs, Cardiology, Radiology, Hospital Equipment, Orthopaedics, General Surgery, Gastroenterology & Urology, Anesthesiology & Respiratory System, representing 93% of total FSCAs, and the rest of Medical Areas, being only the 7%.

The following figure shows the aggregated number of FSCAs by Medical Area:

Top FSCAs in Medical Areas by Region:

 

Relevant Insights: 

  • USA is the country with the highest number of FSCAs (1092), more that the double with respect to the second country, Switzerland (519).
  • After USA, European Countries represent the higher positions: Switzerland (519), Germany (444), Italy (350), Spain (328) and United Kingdom (302).
  • The European Region has 2.5x the number of North America FSCAs, in absolute numbers.

The following figures represent the total aggregated number of FSCAs by Country and by Region:

 

REGION NORTH AMERICA EUROPE* ASPAC LATAM (Only Brazil)
TOTAL FSCAs 1279 3124 1000 154

*FSCA of the same product may have occurred in different EU Countries under the same CE Mark. These are absolute numbers.

Relevant Insights: 

  • Slightly ascendent trend at global level over the last 5 months, registering 1356 FSCAs in May 2019 in those 21 Countries.
  • In Europe, there is a continuous fluctuation around the 600 FSCAs/month, representing a big percentage of the global FSCAs,
  • By Medical Area, the graph depicts clearly the two differentiated groups mentioned in the figure 1 above. For the lower FSCAs Medical Areas group, all of them keep low over the period, with no significant peaks or alterations on the trend. Regarding the higher Medical Areas group, FSCAs fluctuate at different levels, being IVDs and Cardiology in ascendent trend over the last months.

The figure below represents the total FSCAs trend regarding all 21 markets covered:

Trends by Regions:

 

Trends by Medical Areas:

Relevant Insights: 

  • 744 Manufacturers have had FSCAs this year 2019 so far,  in those 21 countries.
  • Philips, Abbott, Siemens, Medtronic and ZImmer Biomet are the 5 Manufacturers with higher number of FSCAs so far in 2019.

* For classifications by Medical Area and exact numbers and cases, or the full 744 Manufacturers list, log in or get in touch with us.

Top 20 Manufacturers with higher number of FSCAs this year 2019 to date:

POSITION MANUFACTURER TOTAL NUMBER FSCAs FSCAs MEDICAL AREA
1 Philips Medical Systems 200-300 Radiology, Cardiology, Hospital Equipment
2 Abbott 200-300 In Vitro Diagnostic (IVD), Cardiology, Gastroenterology & Urology
3 Siemens 200-300 Radiology, In Vitro Diagnostic (IVD), Cardiology, Hospital Equipment
4 Zimmer Biomet 150-200 Orthopaedics, Dental
5 Medtronic 150-200 Cardiology, Hospital Equipment, General Surgery, Neurology, Radiology, Gastroenterology & Urology
6 GE Healthcare 150-200 Radiology, Cardiology, Anesthesiology & Respiratory System, Obstetrics
7 Maquet Cardiovascular 150-200 Cardiology, General Surgery
8 Roche Diagnostics 100-150 In Vitro Diagnostic (IVD)
9 Edwards Life Sciences Ltd. 50-100 Cardiology, Hospital Equipment, Gastroenterology & Urology
10 Cook 50-100 Gastroenterology & Urology, Cardiology, Hospital Equipment, General Surgery
11 Boston Scientific 50-100 Cardiology, Gastroenterology & Urology, General Surgery, Gynaecology, Neurology, Hospital Equipment
12 Johnson & Johnson 50-100 General Surgery, Orthopaedics, Ophthalmology, Wound care
13 Covidien 50-100 General Surgery, Cardiology, Gastroenterology & Urology, Hospital Equipment
14 Arrow  50-100 Hospital Equipment, Cardiology
15 Dräger Medical AG & Co. 50-100 Anesthesiology & Respiratory System, Hospital Equipment
16 Randox Laboratories  50-100 In Vitro Diagnostic (IVD)
17 Thermo Fisher Scientific 50-100 In Vitro Diagnostic (IVD)
18 Beckman Coulter 50-100 In Vitro Diagnostic (IVD)
19 Teleflex Medical  50-100 Anesthesiology & Respiratory System, General Surgery, Gastroenterology & Urology
20 Ortho Clinical Diagnostics Co., Ltd. 50-100 In Vitro Diagnostic (IVD)


Full list (744) Manufacturers with FSCAs access here, only for Subscribers.

 

Relevant Insights: 

  • EU Countries as Switzerland (147) and Germany (106) have nearly the same number of FSCAs as USA (136) regarding IVDs, being those much smaller markets. Switzerland has higher number of FSCAs than USA.
  • The percentage % of IVDs FSCAs of total FSCAs in EU countries is considerably higher (27%) than other areas, being more than the double that the percentage in the USA (12%).
  • Outside of USA and Europe, rest of the world % fluctuates between USA and European Countries, but closer to the EU Countries average figures.

Figures showing Top 5 Countries with IVD FSCAs and percentage % of IVD FSCAs with respect to the total in each area:

 

Relevant Insights: 

  • Cardiology ranks top Medical Area in both Class 1 and Class 2 Recalls in the USA
  • IVDs represents only 3% in Class 1, but 11% in class 2 Recalls. On the Contrary, Anesthesiology & Respiratory System represents 14% Class 1, but only 1% in Class 2.
  • Orthopaedics register similar figures in Class 1 (17%) and Class 2 (20%)

Figures showing percentage % of Medical Areas by Class 1 and 2 Recalls in the USA:

 

This information is based on the information made available by Authorities, and then structured, normalized, categorized, and cleaned by the MedBoard data team. If you wish to obtain more granular data specific to your needs and interests, or in-depth data about rationales, related products, competition, or other, or to get the full report, please get in touch with us.


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