Z-0731-2025Class II

20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction...

Name: Z-0731-2025 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction...
Creator: Abbott Vascular Inc
Published: 2024-11-06
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2024-11-06 / Open, Classified

FDA source

Abbott Vascular Inc began a recall of 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices... on 2024-11-06. FDA classified it as Class II and gives the reason as "Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0731-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-06
Posted: 2024-12-20
Recalling firm: Abbott Vascular
Product: 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
FDA root cause: Component change control
Action: On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902
Quantity in commerce: 3,673
Distribution: US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.
Product codes and lots: UDI-DI: 08717648013614, Lots: 60538750, 60538751, 60539113, 60545329

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0731-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0730-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0731-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0732-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0733-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20

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)