NA BT725Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994744975), received between Dec 6, 2024 and Jan 15, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 other recall cover devices cleared under the same FDA submission (K812292); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A SUCTION AND ANTICOAGULANT ASSEMBLY, IT WAS REPORTED THAT THE OUTER PACKAGING OF WAS DAMAGED, COMPROMISING THE STERILE ENVIRONMENT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077875 ↗
• MalfunctionDec 6, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EL RESERVOIR, AUTOLOG WASH KIT AND SUCTION AND ANTICOAGULANT ASSEMBLY, IT WAS REPORTED THAT THE PRODUCT SUDDENLY FRACTURED AT THE CONNECTION POINT OF THE TUBING TO THE IV FLUID DRIP, CAUSING FLUID TO SPILL ONTO THE FLOOR AND THE TUBING TO FALL, BECOMING CONTAMINATED. THE CUSTOMER IMMEDIATELY PICKED IT UP AND HANDLED THE SITUATION. THE CUSTOMER ASSESSED THAT THE COLLECTED BLOOD HAD BEEN EXPOSED TO CONTAMINATION, RAISING CONCERNS ABOUT INFECTION, AND DETERMINED THAT THE ENTIRE SET NEEDED TO BE REPLACED. TO ENSURE THE PATIENT'S TRANSFUSION SAFETY, A NEW SET OF AUTOLOGOUS BLOOD RECOVERY SUPPLIES WAS REPLACED. BLOOD COLLECTION AND WASHING WERE RESTARTED. AFTER THE SURGERY, THE PATIENT EXPERIENCED NO ADVERSE REACTIONS FROM THE AUTOLOGOUS BLOOD TRANSFUSION. SEE ATTACHED PHOTO. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT'S OWN BLOOD WAS TRANSFUSED. THERE WAS NO ISSUE WITH THE EL RESERVOIR OR WITH THE AUTOLOG WASH KIT. DUE TO THE SURGEON'S FOCUS ON THE OPERATION, THE EXTRACORPOREAL CIRCULATION TECHNICIAN INFORMED THE SURGEON POST-SURGERY. SINCE, NO ABNORMAL EVENTS OCCURRED, THE SURGEON DID NOT INVESTIGATE THE CAUSE FURTHER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20864792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K812292. One submission often covers many models, so check the product and lot details in each record.

• Z-0786-2019 · Nov 27, 2018 · Open, Classified
  SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and rese