PV Bulletin

Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Drug safety and regulatory intelligence for QPPV, Signal, Labeling, PV Ops, and Device Vigilance — daily briefings with operational next steps.
Urgency: high

Latest intelligence

publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Urgency: High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
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publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Atellica CH Revised C-Reactive Protein (RCRP) Safety Information - Siemens Healthcare Diagnostics

Urgency: High

Laboratories must implement the safety measures as indicated by the action registration number R2625739, effective from the notice date of September 7, 2026.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of StrykeFlow PS Irrigation/Suction Devices and AHTO Tubing – Stryker

Urgency: High

Clinics and healthcare facilities are required to verify their inventory immediately and isolate any affected units to prevent accidental use.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Urgent Withdrawal of Reusable da Vinci S and Si Instruments Due to Cable Degradation

Urgency: High

Healthcare facilities must isolate the affected instruments and notify Intuitive Surgical for returns while preparing for potential delays in surgical procedures due to instrument replacements.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Latest
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Urgent Safety Notification - da Vinci X and Xi Instruments - Intuitive Surgical

Urgency: High

Healthcare providers using da Vinci X and Xi instruments must report any incidents associated with cable degradation and follow updated guidelines for the safe use of these instruments.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

ANSM (France) - Safety information feed: Trocart à ballonnet structurel Auto Suture et trocart à pointe émoussée Auto Suture de Covidien – Medtronic sur le site de l'Agence nationale de sécurité du médicamentet des produits de santé Information

Urgency: High

Health professionals must ensure adherence to the manufacturer’s instructions when using the affected devices, including appropriate trocar size selection and avoiding excessive force.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM · France · Updated Sep 7, 2026Translated From French

Injunction No. 2026-DM-031-INJ Regarding Ortho Partner Establishment in Montreuil

Urgency: High

Establish compliant storage conditions for medical devices and set up a non-conformity management system within 3 months.

Inspection ReadinessRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward