Medtronic recalls BIO CAL(R) Temperature Controllers (Models 370 and 370I) due to inability to develop a safe cleaning protocol. Affected units must be discontinued and disposed of immediately.
Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course of action is to request BIO CAL users to discontinue use and dispose of BIO CAL devices.
Medtronic is recalling BIO CAL(R) Temperature Controllers (Models 370 and 370I) because they cannot create a safe cleaning protocol for these devices. Users must stop using and dispose of the recalled units immediately to avoid potential risks.
Medtronic has determined they cannot create a cleaning protocol that meets industry standards. As a result, the devices pose a risk of improper cleaning, which could lead to contamination or other safety issues during medical procedures.
Users of the BIO CAL(R) Temperature Controller during cardiopulmonary bypass procedures are affected. Medical professionals using these devices for blood temperature control are most at risk.
The recalled units are Models 370 and 370I with specific serial numbers listed in the record. These devices are used for controlling patient blood temperature during heart surgery.
Immediately stop using the BIO CAL(R) Temperature Controller and dispose of it safely.
Medtronic has been unable to develop a cleaning protocol that meets industry standards, so they recommend discontinuing use and disposal of the devices.
Models 370 and 370I with specific serial numbers listed in the recall notice.
No, the recall requires users to stop using and dispose of the device immediately; replacements are not provided.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0900-2018 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-0900-2018 from Medtronic Perfusion Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
