CLASS II ONGOING Device recall · Reported 20 Apr 2022 · FDA Enforcement Report

Indeflator Plus recalled by Abbott Vascular

Abbott Vascular is recalling Indeflator Plus 30, distributed nationwide in the US. The recall was initiated on 11 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Numbers: 1000183 Device Identifier-GTIN: 08717648013584 Lot Numbers: 60316775 60322179 60328352 60322176 60326322 60337153

Quantity recalled6 lots

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0924-2022
FDA event ID: 89760
Recalling firm: Abbott Vascular, Temecula, CA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Mar 2022
FDA classified: 13 Apr 2022
Reported: 20 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

11 Mar 2022	Recall initiated by company
13 Apr 2022	Classified by FDA	+33 days
20 Apr 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 89760

This product is part of a recall event; the main page for the event is Plus 30 Priority Pack w/.096 RHV recalled by Abbott Vascular.

Reported	Class	Recall	Company	Reason	Where
20 Apr 2022	CLASS II	Plus 30 Priority Pack w/.096 RHV recalled by Abbott Vascular	Abbott Vascular	Packaging Defects	Nationwide
20 Apr 2022	CLASS II	20/30 Indeflator -REF 1000184 WPL2122268-01 (2019-03-01) recalled	Abbott Vascular	Packaging Defects	Nationwide
20 Apr 2022	CLASS II	20/30 Priority Pack Accessory Kit/.096 RHV recalled by Abbott Vascular	Abbott Vascular	Packaging Defects	Nationwide
20 Apr 2022	CLASS II	20/30 Priority Pack w/Copilot recalled by Abbott Vascular	Abbott Vascular	Packaging Defects	Nationwide

More recalls from Abbott Vascular

All 42

Reported	Class	Recall	Company	Reason	Where
1 Jan 2025Device	CLASS II	20/30 Priority Pack Kit/.115 RHV recalled by Abbott Vascular	Abbott Vascular	Packaging Defects	40 states
1 Jan 2025Device	CLASS II	20/30 Indeflator, REF: 1000184, for use during cardiovascular recalled	Abbott Vascular	Packaging Defects	40 states
1 Jan 2025Device	CLASS II	20/30 Priority Pack Accessory Kit/.096 RHV recalled by Abbott Vascular	Abbott Vascular	Packaging Defects	40 states
1 Jan 2025Device	CLASS II	20/30 Priority Pack Accessory Kit w/Copilot recalled by Abbott Vascular	Abbott Vascular	Packaging Defects	40 states
26 Oct 2022Device	CLASS II	Product/Part: MitraClip G4 CDS NT Repair-mr recalled by Abbott Vascular	Abbott Vascular	Device Malfunction	Nationwide

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