Classification: Official
Publication reference: PRN02516

To:

• NHS Trust:
  • communication leads
  • chief operating officers
  • medical directors
  • heads of procurement
  • heads of emergency preparedness, resilience and response (EPRR)
  • nursing directors
  • directors of communication
  • materials management teams
• Independent sector partners if relevant (via trusts)

cc.

• Regional
  • chief operating officers
  • directors of communication
  • deputy directors of EPRR
  • medical directors
  • directors of nursing
• Integrated care board (ICB):
  • EPRR leads
  • medical directors
  • procurement leads
  • directors of nursing

Dear colleagues,

Kimal – disruption to the supply of medical equipment and consumables

We are writing to update you on a disruption to the supply of procedure packs used in cardiology, following the identification of defects in manifolds and syringes. These products are manufactured by Medline, and then included in procedure packs sold by Kimal in the UK.

Clinical risks and field safety notices

The following Field Safety Notices have been sent to customers:

• Recall of packs containing Namic White Star Handle Manifolds included in Medline’s Namic Systems– noting a risk of foreign particulate within the fluid pathway of Namic White Star Manifolds, which could under certain conditions result in embolism or major harm. Kimal FSN MHRA ref: 2026/004/017/601/053, Medline MHRA ref: 39595226 2026/005/019/601/092
• Angiograph Control Syringe with Rotating Adaptor (RA) fitting in Kimal Procedure Pack – noting a risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and / or full disconnection between syringe and manifold, with associated risk of introduction of air into the line and potential air embolism, as well as possible biohazard exposure, blood loss, and infection. Kimal FSN MHRA ref: 2026/004/017/601/048, Medline FSN MHRA ref: 39595226 2026/005/019/601/092

Kimal have now re-started the supply of affected procedure packs with stickers warning that they should only be used in life-threatening emergency situations.

As of 22 May 2026, the Medicines Health Regulations Authority (MHRA) has issued an updated Device safety information note: DSI/2026/002 which provides more detailed information on the above definition.

The updated device safety information (DSI) changes the wording from ’emergency situations’ to ‘urgent procedures’. This reflects how procedures are classified in the clinical settings where these devices are used, and enables clinicians to take a risk-based approach when deciding whether to use the affected manifolds. MHRA continue to investigate and liaise with Kimal.

Implications for care

If healthcare professionals judge that continued use of the impacted products in Kimal procedure packs is necessary, they should carefully assess the case for use and overall risk of not proceeding if no alternatives are available and implement risk mitigation measures when using the impacted products.

Further advice and context are available in the MHRA DSI and the communication of 22 May 2026 from the British Cardiology Intervention Society which is also enclosed with this cascade.

Local clinician-led risk assessment and informed patient consent will be key.

Where unaffected stock is available, it should be used first – irrespective of the type of procedure. Any remaining locally held affected stock should be retained for use in the event that the supply of unaffected stock is interrupted.

Current supply and availability

We understand that Kimal hold approximately one month’s supply of affected procedure packs (at normal ordering volumes) and this is already in the UK. However, this may include different configurations of procedure packs that your trust and clinicians are not familiar with.

Kimal also currently hold a very limited amount of previous unaffected procedure packs in the UK; however, they are prioritising these for emergency orders only.

Further supplies of unaffected manifolds have arrived in the UK this week and will be distributed by Kimal as soon as possible, beginning today (22 May 2026), providing unaffected stock to use over the coming bank holiday weekend and into next week. These should be used in conjunction with the other contents of the procedure packs.

There is currently no replacement stock available for the syringes, but work continues with Kimal and Medline to support this and alternatives are available.

Given the disruption to the manufacture of these products by Medline as well as the distribution of stock by Kimal, there may be an extended period of pressure on supply.

For day-to-day updates on supply and ordering, please refer to NHS Supply Chain’s ‘Important Customer Notice’ (ICN): Field Safety Notice Kimal Namic White Star Handle Manifolds and Namic Rotating Adaptor Syringes (ICN 3326). This will be kept updated.

Next steps and contact details for queries

Patient safety and clinical concerns

If trusts have any concerns about persistent particulate matter or patient harm following use of the flushing process, please escalate to the National Operations Centre immediately at england.nationaloperationscentre@nhs.net as well as undertaking usual local safety processes.

Should colleagues observe syringes unscrewing or particulates present in manifolds, they should complete a Yellow Card report to support MHRA’s on-going monitoring: yellowcard.mhra.gov.uk.

Supply issues and escalation

Department of Health and Social Care (DHSC), NHS England and NHS Supply Chain will continue to work with Kimal and alternative suppliers to minimise the length of disruption and maximise the availability of clinically acceptable alternatives. We will continue to review how stock is allocated as equitably as possible across trusts, based on need and your feedback.

If trusts have concerns regarding supply, they should follow the process for reporting potential supply disruptions of medical equipment and consumables.

Please contact Kimal in the first instance and ensure your NHS Supply Chain Customer Services Advisor and ICS Manager are aware (if you purchase via this route).

Should there remain supply concerns and if you require urgent support, DHSC’s National

Supply Disruption Response (NSDR) service should be informed at: nsdr@dhsc.gov.uk

Ongoing updates

Updates will be provided in due course via the Important Customer Notice webpage, British Cardiovascular Intervention Society (BCIS), and through existing meetings and networks.

Your co-operation and proactive engagement are vital to the success of this strategy, ensuring we continue to provide safe and effective care across all settings.

Yours sincerley,

Professor Simon Ray, National Clinical Director for Heart Disease, NHS England
Dr Dawn Adamson, National Speciality Advisor for Heart Disease; Chair of Heart Attack and OOHCA Expert Advisory Groups, NHS England