Abbott Vascular Inc: Device Recall

Recall Details

Recall Number

Z-0730-2025

Classification

Class II

Product Type

Device

Recalling Firm

Abbott Vascular Inc

Status

Ongoing

Date Initiated

11/06/2024

Location

Temecula, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,418

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.

Product Description

20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.

Distribution Pattern

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.

Other Recalls by Abbott Vascular Inc

• Class II: Risk 11/06/2024
  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.
• Class II: Risk 11/06/2024
  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.
• Class II: Risk 11/06/2024
  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.

View all recalls by Abbott Vascular Inc →