CryoLife recalls Cryopatch SG Pulmonary Human Cardiac Branch (SGP020) after autopsy reports found morphine in urine. Affected units have specific serial numbers.
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
CryoLife is recalling a specific type of heart branch device after autopsy reports found morphine in the urine of patients who used it. This suggests the device may have been linked to morphine exposure in some cases.
The recall is based on autopsy reports showing morphine in the urine of patients who used the device. This indicates possible morphine exposure through the device, though the exact mechanism is unclear from the report.
Patients who received the Cryopatch SG Pulmonary Human Cardiac Branch device with serial number 10988328 are likely affected. Medical professionals using this device for cardiac procedures may also be at risk.
Check for the product name 'Cryopatch SG Pulmonary Human Cardiac Branch' with catalog number SGP020 and serial number 10988328. This specific unit was distributed in the U.S. and is the only affected model.
Identify if your device has catalog number SGP020 and serial number 10988328.
The recall is based on autopsy reports finding morphine in the urine of patients who used the device, but the exact cause is unclear.
The recall record does not specify any remedy or action for affected devices.
Look for the product name 'Cryopatch SG Pulmonary Human Cardiac Branch' with catalog number SGP020 and serial number 10988328.
We’ve drafted a message you can send CryoLife to request your refund or repair — edit it as you like.
Subject: Recall Z-2272-2018 — CryoLife CryoLife Hello, I own a CryoLife that is covered by recall Z-2272-2018 from CryoLife. 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.
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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.