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Moderate riskFDA DeviceClass II

Merit Medical Allwell Angioplasty Pack recalled for detachable inflation device handle

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.

From the FDA notice · Read the official notice ↗ · All Merit Medical recalls

What to do

  1. Stop using affected angioplasty packs immediately if you have them in inventory.
  2. Check your stock for the affected lot numbers (I2563105 through I3268362).
  3. Contact Merit Medical Systems or your supplier for instructions on return or replacement.
  4. Report any use of affected packs to Merit Medical or the FDA.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Allwell Angioplasty Pack REF: IS-30-B1/B
Sold in
Nationwide
Made for
All ages (18 years to 100 years)

This recall covers 7 products — see all of them.

Details

Units affected
328000 units
Illnesses reported
None reported
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Classification
Class II
Recall number
Z-1129-2026

In the FDA's words

Description
Allwell Angioplasty Pack REF: IS-30-B1/B Inflation device handle may detach from the syringe during procedure. UDI:00884450653388/ Lot: I2563105 I2563106 I2565007 I2598114 I2598131 I2607891 I2612499 I2618005 I2623057 I2632527 I2632528 I2639728 I2661908 I2669772 I2669774 I2827091 I2827094 I2844360 I2844361 I2897482 I2897483 I2897484 I2897485 I2924663 I2972425 I2972426 I2972427 I2972428 I2999054 I3014683 I3030198 I3048363 I3055799 I3080949 I3089230 I3099150 I3110034 I3129711 I3129712 I3161408 I3268359 I3268361 I3268362 Distribution: 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 quantity: 328000 units
Hazard
Inflation device handle may detach from the syringe during procedure.

7 products in this recall

Merit Medical inflation devices and kits recalled for handle detachment

Merit Medical is recalling seven inflation devices and kits, including Allwell and Merit Medical products. The inflation device handle may detach from the syringe during a procedure. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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