REVOLUTION REVOLUTION PCRecalls & reported problems
Sorin Group Italia Srl · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033178104777), received between Jan 11, 2017 and Aug 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
1 other recall cover devices cleared under the same FDA submission (K030462, K190650); 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.
Reports received per month
Most reported problems
Device problems
- Crack1
- Device Damaged Prior to Use1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
LIVANOVA RECEIVED A REPORT OF A DROP-BY-DROP BLOOD LEAKAGE FROM REVOLUTION PUMP DUE TO A CRACK OF THE UNIT. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19947493 ↗MalfunctionJan 11, 2017Crack; Device Damaged Prior to Use; Crack; Device Damaged Prior to Use
SORIN GROUP (B)(6) RECEIVED A REPORT THAT THE PORT OF THE REVOLUTION CENTRIFUGAL BLOOD PUMP CRACKED WHEN THE PERFUSIONIST ATTEMPTED TO ATTACH THE TUBING TO THE CENTRIFUGAL HEAD OUTLET DURING PRIMING. THE UNIT WAS SWAPPED OUT FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6241358 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K030462, K190650. One submission often covers many models, so check the product and lot details in each record.
- Z-0193-2010 · Sep 25, 2009 · TerminatedRevolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog# 050300700***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distribut
Other PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE devices
- CENTRIMAG MOTOR 102956Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type2 recalls4 deaths591 reports
- Impella Impella 5.0 AIC Pump SetAbiomed, Inc. · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type3 recalls56 deaths256 reports
- CentriMag™ 102953Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type1 recall35 deaths209 reports
- Impella Impella LD AIC Pump SetAbiomed, Inc. · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type3 recalls9 deaths57 reports
- NA HY8M65R2Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE4 recalls0 reports
- Custom Perfusion System HY8L55R5Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE3 recalls3 reports
- Custom Perfusion System BB6U40R11Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE2 recalls1 report
- NA HY9D36R1Medtronic, Inc. · Pump, blood, cardiopulmonary bypass, non-roller type2 recalls0 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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