Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Medtronic Custom Perfusion Tubing Pack Recalled by Medtronic Perfusion Systems Due to Medtronic is notifying customers who have or may...

Date: February 4, 2016
Company: Medtronic Perfusion Systems
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Perfusion Systems directly.

Affected Products

Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures

Quantity: 9890 (7773 US, 2117 OUS)

Why Was This Recalled?

Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.

Where Was This Sold?

This product was distributed to 25 states: AK, AZ, CA, DE, FL, HI, IL, LA, MD, MA, MN, MS, MO, NE, NJ, NC, ND, OH, OR, TN, TX, VA, WA, WV, WI

Affected (25 states)Not affected

About Medtronic Perfusion Systems

Medtronic Perfusion Systems has 96 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report