My HPRA: Register

Safety communications

This page is for patients, the public and healthcare professionals.

It describes the different communications issued for device safety issues.

How is device safety information communicated?

There are two main types of safety communications:

  1. Field safety notices (FSNs), published by manufacturers.
  2. HPRA safety notices (SNs), published by us.

For more details on these communications, click the menu below. 

Field safety notices

Manufacturers must inform device users if they find a safety issue with their device.

Manufacturers issue FSNs to device users if they find a safety issue.

If your device is affected by a safety issue and you receive a FSN, read it carefully and follow the instructions.

FSNs may have key information or actions, such as:

  • Removal of a device from the market.
  • Updated instructions on how to use a device safely.
  • A patient recall (where patients are to be brought back for re-testing).

We publish a summary of FSNs affecting the Irish market during the first week of each month.

We also publish a list of FSNs circulated to the Irish market where actions remain outstanding.

We can only publish FSNs notified to us.

If you receive an FSN not on our list, please let us know by email at devicesafety@hpra.ie.

 

 

HPRA safety notices

If you receive a FSN from a manufacturer, act on it at once.

Do not wait for a HPRA safety notice . Most FSNs are not accompanied by a HPRA safety notice.

We issue HPRA safety notices to device users when we consider it necessary.

This includes:

  • To give more information to users in Ireland (FSNs often accompany SNs).
  • To raise awareness of a high risk FSN.
  • To raise awareness of an FSN where the manufacturer has not been able to contact all device users.
  • Where a company no longer exists.

More details on our safety notices, including how they are formatted, can be found here.

Anyone can sign up to receive HPRA safety notice by emailing devicesafety@hpra.ie.

What should I do if I receive a HPRA safety notice?

If you are a patient or member of the public, you should:

  • Review the safety notice.
  • Discuss any problems or concerns with your doctor.

If you are a healthcare professional, you should:

  • Ensure the notice reaches the correct person in your organisation.
  • Share the notice with other affected organisations or persons.
  • Review the notice and complete actions as needed.

 



Date Title Type
13/03/2015 Invacare Leo®, Orion® and Comet ® Scooters. Priority 2 – Warning Advisory
05/03/2015 Use of iodine in Peritoneal Dialysis (PD) products. Priority 2 – Warning Warning
03/03/2015 Summary of Field Safety Notices - February 2015 3rd Party Publications
23/02/2015 Information Notice - Medical devices supplied by Atrium Medical (Maquet) Advisory
05/02/2015 Counterfeit Toshiba Ultrasound Transducers - Priority 3 - Advisory Advisory
04/02/2015 Summary of Field Safety Notices - January 2015 3rd Party Publications
02/02/2015 Medical Devices in the Home. Priority 3 – Advisory Advisory
30/01/2015 HeartStart MRx Monitor/Defibrillator Priority 2 – Warning Warning
07/01/2015 Summary of Field Safety Notices - December 2014 3rd Party Publications
19/12/2014 Autopen Classic, Autopen 24, Densupen, Autopen 3ml for Teriparatide. Priority 2 – Warning Warning
17/12/2014 HeartStart MRx Monitor/Defibrillator / Philips M1783A and M5526A Sync Cables - Priority 2 – Warning Warning
15/12/2014 Juvéderm ULTRA 4 Priority 2 – Warning Warning
02/12/2014 Summary of Field Safety Notices - November 2014 3rd Party Publications
26/11/2014 Samaritan PAD 300 / PAD 300P Public Access Defibrillators. Priority 2 – Warning Warning
26/11/2014 RENASYS™ ® range of Negative Pressure Wound Therapy (NPWT) devices. Priority 2 – Warning Warning
06/11/2014 Insulin Infusion Pumps. Priority 3 – Advisory Advisory
05/11/2014 Summary of Field Safety Notices – October 2014 3rd Party Publications
22/10/2014 TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D). Priority 2 – Warning Warning
20/10/2014 Accu-Chek Spirit Combo Insulin pump (Model No. 00700006863). Priority 2 – Warning Warning
03/10/2014 Servo-i Ventilator Battery Modules. Part Numbers: 6487180. Manufacturing Dates: 1005- 1243 (February 1, 2010 – October 25, 2012) Priority 2 – Warning Warning
« First« Previous141516171819202122Next »Last »