Z-0921-2022Class II

20/30 Indeflator -Ref 1000184 Wpl2122268-01 (2019-03-01)

Name: Z-0921-2022 20/30 Indeflator -Ref 1000184 Wpl2122268-01 (2019-03-01)
Creator: Abbott Vascular
Published: 2022-03-11
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2022-03-11 / Open, Classified

FDA source

Abbott Vascular began a recall of 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) on 2022-03-11. FDA classified it as Class II and gives the reason as "Due to an increase in complaint trend for leaks and intermittent/loose connections". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0921-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-11
Posted: 2022-04-13
Recalling firm: Abbott Vascular
Product: 20/30 Indeflator -Ref 1000184 Wpl2122268-01 (2019-03-01)
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Due to an increase in complaint trend for leaks and intermittent/loose connections.
FDA root cause: Component change control
Action: On 03/11/2022, the firm sent an "URGENT FIELD SAFETY NOTICE/DEVICE RECALL" Letter via visit, email or mail, to customers informing them that specific lots of 20/30 INDEFLATOR, INDEFLATOR Plus 30 and associated Priority Packs my exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Customers are instructed to: 1)Immediately stop using the devices from the affected lots 2) Review their inventory, complete and return the provided Effectiveness Check Form 3) Return all unused affected devices to the Recalling Firm 4) Share the Recall Notification with relevant personnel in their organization 5) if the affected products have been further distributed/transferred, notify those customers 6) Report any occurrence of product performance issues or patient adverse events to the Recalling Firm at 800-227-9902 The Recalling Firm: -Has immediately stop shipping devices from affected lots -Conducting an investigation to determine/confirm that there are not other affected products or lots in distribution -Implementing appropriate corrective actions to ensure product performance -Will work to replace inventory when available For questions or assistance contact the local representative or customer service department at 800-227-9902
Quantity in commerce: 17 lots
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0921-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0921-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13
Z-0922-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13
Z-0923-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13
Z-0924-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13
Z-0925-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13

Product code MAV

K961471Class IIIndeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115 Rotating Hemostatic Valve)Advanced Cardiovascular Systems, Inc. / cleared 1996-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)