NA HY11B40R1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000314231), received between Mar 3, 2021 and Mar 9, 2021 — classified as 2 deaths.

The most frequently reported specific device problem is “Nonstandard Device” (1 report).

2 FDA recall records name this device's identifier.

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.

Recalls naming this device

1. Apr 29, 2021Terminated

   Specific lots may have been manufactured with insufficient or incomplete welds.

   Z-1877-2021 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Feb 4, 2021Terminated

   Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

   Z-1195-2021 · Root cause: Device Design · FDA record ↗

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.

• DeathMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON EXECUTION OF FCA CVG-21-Q3-23 MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM PACK A PATIENT EXPIRED. PATIENT WAS TREATED WITH CUSTOM PACK HY11B40R1, LOT #220911913 USED FROM (B)(6) 2021 @ 1455 UNTIL (B)(6) 2021 @ 1334 AT WHICH TIME ELECTIVE CIRCUIT CHANGE WAS PERFORMED DUE TO ELEVATED PLASMA FREE HEMOGLOBIN/HEMOLYSIS. PATIENT BORN AT 41.3 WEEKS GESTATION VIA EMERGENT C-SECTION FOR NON-REASSURING FETAL HEART TONES. THICK MECONIUM NOTED AT DELIVERY. RESUSCITATED AT DELIVERY INCLUDING CHEST COMPRESSIONS >20MINUTES. PATIENT WAS TREATED WITH THERAPEUTIC HYPOTHERMIA FOR HYPOXIC ISCHEMIC ENCEPHALOPATHY PER PROTOCOL. BROAD SPECTRUM ANTIBIOTICS STARTED AFTER DELIVERY. TRANSFERRED TO COA FOR ECMO. PATIENT PLACED ON VA ECMO FOR RESPIRATORY FAILURE, PERSISTENT PULMONARY HYPERTENSION, AND HEMODYNAMIC INSTABILITY DESPITE MAXIMUM MEDICAL SUPPORT. PLACENTAL PATHOLOGY REMARKABLE FOR CHORIOAMNIONITIS AND FUNISITIS. PLACENTAL CULTURE REMARKABLE FOR CANDIDA ALBICANS ON MATERNAL AND FETAL SIDES. FLUCONAZOLE STARTED (B)(6) 2021 WHEN PLACENTAL CULTURE RESULTS RECEIVED, LATER CHANGED TO AMPHOTERICIN B THE SAME DAY. PATIENT BLOOD CULTURE (AEROBIC) FROM (B)(6) 2021 @ 0925 POSITIVE FOR CA

  Patient problems: Ischemia Stroke; Respiratory Failure; Sepsis

  MAUDE report 11442792 ↗
• DeathMar 3, 2021Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  UPON EXECUTION OF FCA CVG-21-Q3-23 MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM PACK A PATIENT EXPIRED. ADDITIONAL INFORMATION RECEIVED: CIRCUIT (LOT #220911913) WAS IN USE UNTIL (B)(6) 2021 @ 1643. BOTH CIRCUITS WERE REPLACED ELECTIVELY FOR THROMBUS/PLAQUE FORMATION THROUGHOUT CIRCUIT. PATIENT WAS PRENATALLY DIAGNOSED WITH RIGHT CDH AND WAS PLACED ON VA ECMO ON DOL 1 FOR RESPIRATORY FAILURE AND PERSISTENT PULMONARY HYPERTENSION, DESPITE MAXIMUM MEDICAL MANAGEMENT. CDH WAS REPAIRED (B)(6) 2020 , PATIENT ENDURED A COMPLICATED POSTOPERATIVE COURSE RELATED TO INTRAABDOMINAL/INTRATHORACIC BLEEDING REQUIRING MULTIPLE RE-EXPLORATIONS AND CHEST TUBE PLACEMENT. PATIENT HAD AN EXTENSIVE ECMO COURSE WITH MULTIPLE CIRCUIT CHANGES AND INTERVENTIONS AND REMAINED ON ECMO SUPPORT UNTIL THE TIME OF HER DEATH WHEN SUPPORT WAS WITHDRAWN. BLOOD CULTURE (AEROBIC) COLLECTED (B)(6) 2021 AT 1405 WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS (MRSA). PATIENT WAS RECEIVING VANCOMYCIN, FORTAZ, AND FLUCONAZOLE AT TIME OF DEATH. CAUSE OF DEATH IS DOCUMENTED AS PERINATAL RESPIRATORY FAILURE ASSOCIATED WITH PERSISTENT PULMONARY HYPERTENSION, CONGENITAL PULMONARY HYPOPLASIA FROM CONGENITAL DIAPHRAGMATIC

  Patient problems: Respiratory Failure; Sepsis

  MAUDE report 11403299 ↗

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 · Terminated
  Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.