Medtronic Perfusion Systems: Medical Device Recall in 2021 - (Recall #: Z-0003-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

Product Classification:

Class II

Date Initiated: September 13, 2021

Date Posted: October 13, 2021

Recall Number: Z-0003-2022

Event ID: 88685

Reason for Recall:

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

Status: Ongoing

Product Quantity: 168 kits

Code Information:

Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated