【HEADLINES】Multiple Class I Recalls Hit the Industry: Medtronic, Terumo, Abiomed in the Spotlight

The first half of July witnessed a concentrated wave of the most severe (Class I) recalls across the global medical device landscape.

Medtronic Harmony Delivery System – Class I Recall (Again)

On July 13, the FDA classified Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) Delivery Catheter System (DCS) as a Class I recall. The issue stems from a potential distal tip detachment during the implantation procedure. If detachment occurs, secondary intervention via intravascular retrieval or surgery may be required, which could lead to prolonged procedure time, tissue damage, embolization, or hemorrhage. As of May 14, 2026, Medtronic has not reported any serious injuries or deaths related to this issue. The company has instructed customers to immediately quarantine and return affected lots. Patients with successfully implanted Harmony TPVs require no further action. Notably, this same product was subject to a Class I urgent recall in April 2022 for an identical tip‑detachment problem—recurring failure four years after the initial corrective action.

Terumo Relay™Pro Thoracic Stent Graft – Global Voluntary Recall

On July 1, Terumo Corporation announced a global voluntary recall of specific lots of its Relay™Pro Thoracic Stent Graft System. Approximately 7,000 units sold between May 2024 and March 2026 are affected, distributed across 43 countries including North America, Latin America, Europe, the Middle East, and Asia. The recall was prompted by a failure of the delivery system to separate from the stent graft after full deployment, leaving the delivery catheter irretrievable. Four serious adverse events have been reported, including three patient deaths during or immediately after the procedure. Terumo ceased shipments of the affected lots outside Japan in March 2026.

Abiomed Impella CP with SmartAssist – Class I Recall

On July 2, the FDA classified Abiomed’s Impella CP with SmartAssist heart pump kits as Class I. Certain serial numbers do not meet design specifications and may experience low purge‑pressure events, which can trigger persistent alarms and potentially interrupt or terminate mechanical circulatory support.

Windstone Medical Custom Procedure Kits – Class I Correction

On July 6, the FDA designated Windstone Medical Packaging’s custom convenience kit recall as Class I. The affected kits contain Cardinal Health Webcol alcohol prep pads that may be contaminated with Paenibacillus phoenicis. When used for skin antisepsis prior to injections or blood draws, this poses an infection risk for critically ill, immunocompromised, neonatal, and pediatric patients. As of June 4, 2026, no serious injuries or deaths have been reported.

Other FDA Recalls (Class II) – Multiple entries were recorded in early July, including Covidien Shiley Decannulation Stoppers, GORE TAG Thoracic Branch Stent Graft, Bard Groshong NXT and PowerPICC catheters, Olympus single‑use distal protection caps, and ConvaTec Aquacel Ag Surgical SP. Boston Scientific also voluntarily recalled one Intera Oncology INTERA 3000 hepatic artery infusion pump in the US (Class II, now closed). Additionally, the FDA recently issued a warning letter to a CPAP distributor/manufacturer for unauthorized sales and inadequate complaint handling.

【MERGERS & ACQUISITIONS】Global MedTech M&A Remains Robust, H1 Total Reaches $36.5B

In the first half of 2026, global MedTech M&A totaled $36.5 billion, with both deal volume and value exceeding the same period in 2025. Major transactions continued in the first half of July:

· Merck KGaA to acquire Bio-Techne for $11.3B – The all‑cash acquisition has been approved by both boards and awaits shareholder votes and regulatory clearances, with closing expected in late 2026 or early 2027.

· Novartis acquires Myricx Bio for up to $1.5B – On July 6, Novartis signed a definitive agreement to acquire the UK‑based biotech, expanding its oncology pipeline. Myricx, a portfolio company of Novo Holdings, develops novel ADC payloads.

· Vertex acquires Crinetics Pharmaceuticals – Announced July 6, deal terms undisclosed.

· AIP to acquire Avanos Medical for $1.272B – American Industrial Partners’ all‑cash offer is progressing, with closing expected no later than July 27, 2026.

· Zimmer Biomet acquires iovera° for up to $140M – The orthopedics giant acquired Pacira BioSciences’ neuro‑cryoanalgesia platform and associated assets.

Other deals: Kimball Electronics announced the acquisition of Helvoet Polymer Technologies (European CDMO) on July 1; Valerio Therapeutics acquired etherna immunotherapies on July 1; Boustead’s healthcare unit took a majority stake in a medtech firm via a SGD 6M equity injection.

【PRODUCT CLEARANCES】Multiple FDA 510(k) Approvals and CE Marks

Orthopedics

· Zimmer Biomet acquires iovera° for up to $140M – The orthopedics giant acquired Pacira BioSciences’ neuro‑cryoanalgesia platform and associated assets.

· Tyber Medical’s Anteralign LS coverplate received FDA 510(k).

· Movmedix’s LARS ACJ System (acromioclavicular joint) received FDA 510(k).

· Tenon Medical’s Catamaran SI Joint Fusion System received FDA 510(k) update clearance.

Neurovascular

· Penumbra’s Thunderbolt Aspiration Catheter System received FDA clearance for thrombus removal in the neurovasculature.

Ophthalmology

· RxSight’s intraocular lens delivery device received FDA clearance.

Diabetes Management

· CMT Health’s Profoject™ safety pen needle (with post‑use automatic locking shield to prevent needlestick injuries) received FDA 510(k) clearance.

AI Diagnostics

· iHealthScreen’s iPredict‑DR AI‑based diabetic retinopathy screening software received FDA 510(k).

· ZETA SURGICAL’s Zeta TMS robotic system received FDA 510(k).

· Universal Brain’s rapid brain function measurement platform received FDA 510(k).

CE Marks

· Median Technologies’ eyonis® LCS AI lung cancer screening software obtained CE marking.

· Shenzhen New Industries Biomedical Engineering (Snibe) accumulated IVDR CE certifications for 220 chemiluminescence assays and 87 biochemical reagents.

【INDUSTRY NEWS & MARKET TRENDS】

**Medical Taiwan 2026 Wraps Up, Generating Over $160M in Business Opportunities** – The three‑day exhibition, organized by TAITRA, attracted visitors from 63 countries and generated more than US$160 million in smart healthcare deals. Top five buyer sources: Japan, Thailand, Vietnam, the Philippines, and South Korea.

Vietnam Medi‑Pharm Expo 2026 – The 24th edition will be held in Ho Chi Minh City from July 30 to August 1, with over 300 exhibitors from 15 countries expected.

ADLM 2026 (American Association for Clinical Chemistry) – One of the world’s largest IVD exhibitions, ADLM 2026, will take place July 26–30 in Anaheim, California.

Dexcom G7 Sensor Theft Alert – On July 3, New Zealand’s Medsafe issued an alert that two lots of Dexcom G7 sensors were stolen during destruction and subsequently sold by a third party in the US market.

Disclaimer: This article is for medical popularization, purposes only and does not constitute professional medical advice. Please always follow the diagnosis and treatment plans provided by your treating physician.