NA BB7U21R19Recalls & reported problems
Medtronic, Inc. · CUSTOM PACK BB7U21R19 TABLE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000139506), received between Jun 20, 2023 and Jun 20, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 other recall cover devices cleared under the same FDA submission (K171308); 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
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE CUSTOM PACK CARDIOPLEGIA COIL OUTLET LEAKED BLOOD. THE PRODUCT WAS REPLACED. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION: 5ML OF BLOOD WAS LOST DUE TO THE LEAK NO TRANSFUSION WAS REQUIRED NO DAMAGE WAS NOTED TO THE DEVICE IN THE VICINITY OF THE LEAK THERE WAS NO VISIBLE AIR IN SYSTEM/TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17161057 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171308. One submission often covers many models, so check the product and lot details in each record.
- Z-0535-2018 · Jan 3, 2018 · TerminatedMedtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Other Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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