Merit Medical Systems recalled 328,000 angioplasty packs on December 4, 2025, due to a risk of the inflation device handle detaching during procedures. The recall affects devices distributed worldwide, including states across the U.S. Healthcare providers and patients must stop using the devices immediately.
Inflation device handle may detach from the syringe during procedure.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The Allwell Angioplasty Pack is a medical device used during angioplasty procedures to inflate balloons or stents. Healthcare providers use it to treat narrowed arteries and improve blood flow. Patients rely on this device for essential cardiovascular procedures.
The handle of the inflation device may detach from the syringe during use, which can lead to complications during medical procedures. This defect compromises patient safety and may affect the efficacy of the treatment.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must cease using the affected packs, which could disrupt ongoing medical treatments. The high risk of detachment raises concerns for patient safety and may necessitate alternative treatments.
The UDI code can typically be found on the product packaging or the instruction manual.
Refund or replacement processing can take approximately 4-6 weeks.
Keep a record of your purchase, any communications about the recall, and photographs of the product.
The recalled product is the Allwell Angioplasty Pack, REF: IS-30-B1/B. It has been distributed globally, including in all U.S. states and several countries. The devices were sold under multiple model numbers including UDI: 00884450653388.
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