· All metal-on-metal (MoM) hip replacements: updated advice for follow-up of patients
MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018)
Alert type:
Medical device alert
Medical specialism:
General practice and 3 others
Issued:
29 June 2017
· BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment
Manufactured by Intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 5 others
Issued:
21 June 2017
· DePuy Synthes Radial Head elbow prosthesis system: risk of post-operative loosening of the radial stem
Manufactured by Synthes GmbH - Recall of Radial Head Prosthesis System.
Alert type:
Medical device alert
Medical specialism:
Orthopaedics
Issued:
12 June 2017
· Solus Flexible Wire Reinforced Laryngeal Mask Airway – risk of hypoxia due to partial or total occlusion of the airway tube after inflating the cuff
Manufactured by Intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 6 others
Issued:
9 June 2017
· All HeartStart MRx defibrillators – possible failure to deliver a shock, cardioversion, pacing or monitoring
Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 18 others
Issued:
24 May 2017
· All LIFEPAK 1000 automatic external defibrillators (AEDs) - risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy
Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 21 others
Issued:
18 May 2017
· V60 ventilator – potential for unexpected shutdown
Manufactured by Philips Respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 3 others
Issued:
17 May 2017
· Biological replacement pericardial aortic heart valve: Mitroflow LX (sizes 19mm and 21mm) – risk of early structural valve deterioration
Manufactured by LivaNova – increased risk of earlier than anticipated structural valve deterioration (SVD) particularly with the smaller sizes.
Alert type:
Medical device alert
Medical specialism:
Cardiology
Issued:
3 May 2017
· All Accu-Chek® Insight insulin pumps – updated information for battery management
Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
Alert type:
Medical device alert
Medical specialism:
Care home staff and 3 others
Issued:
2 May 2017
· BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy
Manufactured by Becton Dickinson (BD) – product recall due to leak around the stopper which can result in under-dose or exposure of clinicians or patients to cytotoxic drugs.
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 7 others
Issued:
24 April 2017
· LMA mucosal atomization devices - topical anaesthesia may not be delivered in a fully atomised spray
Manufactured by Teleflex – Poor atomisation of the spray could result in inadequate topical anaesthesia delivery, which may lead to discomfort or difficulties delivering anaesthesia
Alert type:
Medical device alert
Issued:
24 April 2017
· LMA® MAD Nasal™ intranasal mucosal atomization device – might not deliver a fully atomised plume of medication
Manufactured by Teleflex – failure of the device to deliver an atomised plume may impair the effectiveness of the medication, potentially resulting in serious injury or a life-threatening situation
Alert type:
Medical device alert
Issued:
21 April 2017
· All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine
Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 4 others
Issued:
12 April 2017
· Comprehensive Reverse Titanium Shoulder Tray (specific lots) - risk of device fracture
Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
Alert type:
Medical device alert
Medical specialism:
General practice and 2 others
Issued:
4 April 2017