FDA-Device2026-01-28Class IIPROCESSING DEFECT
Merit Medical Allwell Angioplasty Pack recalled for detachable inflation device handle
OTHERNationwide distribution
Stop using Merit Medical angioplasty packs
Merit Medical Systems is recalling certain Allwell Angioplasty Packs because the inflation device handle may detach from the syringe during a procedure. This could interrupt treatment and require the procedure to be stopped or repeated. No injuries have been reported.
- Stop using affected angioplasty packs immediately if you have them in inventory.
- Check your stock for the affected lot numbers (I2563105 through I3268362).
- Contact Merit Medical Systems or your supplier for instructions on return or replacement.
- Report any use of affected packs to Merit Medical or the FDA.
Hazard
Inflation device handle may detach from the syringe during procedure.
Sold states
Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.
Affected count
328000 units
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Allwell Angioplasty Pack REF: IS-30-B1/B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1129-2026More Merit Medical Systems, Inc. recalls
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