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14,953 results

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Urgent Field Safety Notice for Impella Purge Cassette by ABIOMED Inc. PDF, 55KB, File does not meet accessibility standards Date: 22. June 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 11881/21

Urgent Field Safety Notice for CASE / CardioSoft Cardiac Testing System by GE Medical Systems Information Technologies PDF, 225KB, File does not meet accessibility standards Date: 22. June 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 11820/21

Urgent Field Safety Notice for fabian HFO, +nCPAP evolution and Therapy evolution by Acutronic Medical Systems AG PDF, 281KB, File does not meet accessibility standards Date: 22. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 08040/21

Urgent Field Safety Notice for Jelonet (5 cm x 5 cm) "EurimPharm" by Smith & Nephew Medical Ltd. PDF, 1MB, File does not meet accessibility standards Date: 22. June 2021 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 11321/21

Urgent Field Safety Notice for Dimension Vista High Sensitivity Troponin I Flex by Siemens Healthcare Diagnostics Inc. Newark PDF, 1MB, File does not meet accessibility standards Date: 21. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 11705/20

URGENT: FIELD SAFETY NOTICE Philips Respironics CPAP and Bi-Level PAP Devices PDF, 111KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11652/21

URGENT: FIELD SAFETY NOTICE Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models PDF, 111KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11651/21

Urgent Field Safety Notice for VivaDiag SARS-CoV-2 Ag Rapid Test by VivaChek Biotech (Hangzhou) Co., Ltd. PDF, 96KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05458A/21

Urgent Field Safety Notice for Anse sterili per inoculazione by APTACA S.p.A. PDF, 369KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 08902/21

Urgent Field Safety Notice for Medtronic CoreValveTM EvolutTM R System, Medtronic CoreValveTM EvolutTM PRO System by Medtronic CoreValve, LLC PDF, 187KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 11768/21

Urgent Field Safety Notice for Atellica UAS 800 analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 42KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10300/21

Urgent Field Safety Notice for Sabouraud 2 agar (SAB2-T) by bioMérieux S. (Marcy- l'Etoile) PDF, 668KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 10319/21

Urgent Field Safety Notice for DiGeorge/VCFS N25 and 22q13.3 Deletion Probe by Cytocell Ltd PDF, 44KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 10528/21

Urgent Field Safety Notice for DiGeorge/VCFS TUPLE1 and 22q13.3 Deletion Probe by Cytocell Ltd PDF, 123KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 10527/21

Urgent Field Safety Notice for Randox NEFA (Non-esterified fatty acid) by Randox Laboratories Ltd PDF, 221KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10018/21

Urgent Field Safety Notice for Atellica CH 930, IM 1300, IM 1600 Analyzers by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 76KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09937/21

Urgent Field Safety Notice for Creatine Kinase-MB (CK-MB) by Beckman Coulter Ireland Inc. PDF, 141KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10068/21

Urgent Field Safety Notice for Freelite Human Kappa Free Kit on Roche Cobas by The Binding Site Group Limited PDF, 268KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10064/21

Urgent Field Safety Notice for E2A (TCF3) Breakapart by Cytocell Ltd PDF, 45KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10549/21

Urgent Field Safety Notice for TCL1 Breakapart Probe by Cytocell Ltd PDF, 43KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10529/21

Have other EU Member States carried out a recall of PIP implants? Date: 15. June 2021 Topics: Medical devices Type: FAQ

The European Commission has been informed by France and strongly advises the competent authorities of other EU Member States, warned by Afssaps, to take all useful and necessary measures in order to verify the involved implants are no longer …

Should health-care facilities destroy the PIP implants still in stock? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Afssaps has not requested the destruction of these products. However, the terms of the decision imply the products should not be used as long as the suspension decision is in effect. Neither the scheduled analyses nor the legal procedure in progress …

How are the complications following the rupture of a PIP implant covered? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Regarding the coverage of complications due to silicone gel leakage from a breast implant, Social Security indicates that if it has not covered the initial breast implant surgery (in the case of aesthetic surgery), it will only cover, the medical …

What kind of tests are performed on the PIP company implants and when will the results be disclosed? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Three types of analyses are being performed on the PIP implants:

  • characterisation of different silicone gel used,
  • evaluation of implants properties as well as used gel properties in order to characterise the implants resistance and particularly the …

According to Afssaps what should be done with the removed implants? Date: 15. June 2021 Topics: Medical devices Type: FAQ

What should be done with removed implants is up to the patient. Laboratory controls currently in progress do not require the gathering of removed implants. They are performed on prostheses taken from different stocks.

What long-term medical follow-up should I have? Date: 15. June 2021 Topics: Medical devices Type: FAQ

You must follow the usual recommended follow-up and have an ultrasound performed every year.

Who should I contact to get further information? Date: 15. June 2021 Topics: Medical devices Type: FAQ

First, you should contact your surgeon or your doctor. A free number (0800 636 636) has also been set up at Afssaps.

If they are removed, can they be replaced? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Usually, the insertion of new implants is possible. Your surgeon will explain the conditions.

Should I have my breast implants removed? Date: 15. June 2021 Topics: Medical devices Type: FAQ

To date, according to experts, nothing justifies a preventive replacement of the implant under which the surgery may be considered.

What are the symptoms of an implant rupture? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Most of the time implants rupture without any symptom. An implant rupture can be detected during a clinical examination. The health professional will prescribe additional examinations if necessary. For this reason it is important to regularly keep up …