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

FDA Device Recall #Z-0923-2022 — Class II — March 11, 2022

Recall Summary

Recall Number Z-0923-2022
Classification Class II — Moderate risk
Date Initiated March 11, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Abbott Vascular
Location Temecula, CA
Product Type Devices
Quantity 131 lots

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Lot / Code Information

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

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Z-0116-2023 Class II Product/Part: MitraClip NTR Clip Delivery Syste... Sep 8, 2022
Z-1095-2022 Class I Dragonfly OpStar Imaging Catheter, REF 1014651/... Mar 30, 2022
Z-0924-2022 Class II INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 ... Mar 11, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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