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 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.
The inflation device handle may detach from the syringe during use, posing a high risk of injury during medical procedures. This defect can lead to complications in treatment and patient safety.
There have been no specific injury reports associated with this recall at this time. However, the potential for harm during procedures remains significant.
Patients and healthcare providers should stop using the angioplasty packs immediately. Contact Merit Medical Systems, Inc. or your healthcare provider for specific instructions regarding the recall.
For more details, email Merit Medical Systems, Inc. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1129-2026.
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