Is 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) recalled?

Due to an increase in complaint trend for leaks and intermittent/loose connections. Status: Voluntary: Firm initiated Initial Firm Notification: Letter Distribution: U.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, VA, WA, and WI. O.U.S.: United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, R¿union, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation, Bahamas, Israel, Saudi Arabia, Canada, India, Singapore, Switzerland, Italy, Slovakia, Chile, Jamaica, Thailand, China, Japan, Taiwan Republic of China, Colombia, Korea (South), Costa Rica, Luxembourg, Uruguay, Czech Republic, Mexico, Vietnam, Germany, Netherlands, South Africa, Dominican Republic, New Zealand, Spain, and Panama

Medium RiskFDA Device

Abbott Vascular: Due to an increase in complaint trend for leaks and intermittent/loose connections.

Agency Publication Date: April 13, 2022

Affected Products

Product: 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

Part Numbers: 1000184 Device Identifier-GTIN: 08717648013591 Lot Numbers: 60309678 60320071 60337162 60311336 60320899 60337166 60311338 60331726 60311337 60311339 60331727 60317539 60315914 60334491 60318209 60317535 60334492

Lot Numbers:

Numbers

Product: 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)

Part Numbers: 1000186 Device Identifier-GTIN: 08717648013614 Lot Number: 60317536 60320079 60325409 60317537 60320909 60326623 60317542 60320910 60329936 60318666 60320911 60334116; Part Numbers: 1000186-115 Device Identifier-GTIN: 08717648015274 Lot Number: 60311340 60318662 60329334 60311346 60318663 60334117 60317538 60318664 60334737 60318661 60318665

Lot Numbers:

Number

Product: 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)

Part Numbers: 1003327 Device Identifier-GTIN: 08717648013973 Lot Numbers: 60308571 60315919 60325098 60308572 60316407 60325099 60308573 60317004 60325100 60308574 60317279 60325101 60308575 60317280 60325103 60309671 60317533 60326298 60309672 60317540 60326299 60309673 60317541 60326300 60309674 60317947 60326301 60309675 60317948 60326425 60309676 60318668 60326859 60309677 60318669 60326860 60309681 60318670 60326861 60309682 60319819 60326862 60309683 60320067 60326863 60309684 60320068 60328011 60309685 60320069 60328023 60309686 60320070 60328355 60309687 60320072 60328356 60311341 60320073 60329330 60311342 60320074 60329331 60311343 60320075 60329332 60311344 60320076 60329333 60311345 60320914 60329967 60312167 60322147 60329968 60312168 60322182 60329969 60312169 60322183 60330058 60312170 60322184 60331041 60312171 60322185 60331043 60312172 60323316 60331358 60312173 60323317 60331537 60312174 60323318 60331538 60312175 60323319 60331731 60312176 60323320 60331733 60312177 60323321 60331943 60312178 60323322 60334120 60313415 60323323 60334121 60313416 60323324 60334122 60313417 60323325 60334123 60313418 60323434 60335132 60313420 60323785 60335817 60313421 60323786 60336487 60313422 60323787 60337158 60315918 60325097

Lot Numbers:

Numbers

Product: INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)

Part Numbers: 1000183 Device Identifier-GTIN: 08717648013584 Lot Numbers: 60316775 60322179 60328352 60322176 60326322 60337153

Lot Numbers:

Numbers

Product: Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)

Part Numbers: 1000185 Device Identifier-GTIN: 8717648013607 Lot Numbers: 60317532 60323314 60329935 60323313 60326601 Part Numbers: 1000185-115 Device Identifier-GTIN: 08717648015267 Lot Numbers: 60316763 60323315

Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89760

Status: Active

Manufacturer: Abbott Vascular

Manufactured In: United States

Units Affected: 5 products (17 lots; 23 lots; 131 lots; 6 lots; 7 lots)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

Lot Numbers:

Numbers

Product: 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)

Lot Numbers:

Number

Product: 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)

Lot Numbers:

Numbers

Product: INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)

Part Numbers: 1000183 Device Identifier-GTIN: 08717648013584 Lot Numbers: 60316775 60322179 60328352 60322176 60326322 60337153

Lot Numbers:

Numbers

Product: Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)

Lot Numbers:

Numbers