Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4420
Recent MDR events
243 adverse event reports on file
- DLP PERICARDIAL SUMPJul 9, 2026InjuryMedtronic Grand Rapids3003955307-2026-00198
- DLP PERICARDIAL SUMPMay 18, 2026InjuryMedtronic Grand Rapids3003955307-2026-00085
- MEDTRONIC MINI SUCKERMar 19, 2026MalfunctionMedtronic Grand Rapids3003955307-2026-00020
- DLP LEFT HEART VENT CATHETERSJan 22, 2026MalfunctionPerfusion Systems2184009-2026-00139
- MEDTRONIC MINI SUCKERJan 14, 2026MalfunctionMedtronic Grand Rapids2184009-2026-00066
- MEDTRONIC MINI SUCKERJan 14, 2026MalfunctionMedtronic Grand Rapids2184009-2026-00067
- DLP PERICARDIAL SUMPJan 5, 2026MalfunctionMedtronic Grand Rapids2184009-2026-00007
- DLP PERICARDIAL SUMPJan 5, 2026MalfunctionMedtronic Grand Rapids2184009-2026-00008
- DLP CARDIAC SUCTION TUBEDec 8, 2025MalfunctionPerfusion Systems2184009-2025-01591
- LIVA NOVA WEIGHTED SU CASATION TIPAug 11, 2025InjuryLiva/livanova Usa, Inc.MW5174345
Event type breakdown
Recalls
11 recall events for this product code
- Medtronic Perfusion SystemsOpen, ClassifiedMay 10, 2024
Medtronic Suction Tubes:
Potential for unsealed sterile packing.
Z-1804-2024 · View FDA record ↗ - International Biophysics Corp.TerminatedAug 19, 2015
IBC Suction Wand Catalog Number 1990S
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Z-2422-2015 · View FDA record ↗ - California Medical Laboratories IncTerminatedJan 7, 2013
Sterile Rigid Tip Suction Wand
California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Z-0649-2013 · View FDA record ↗ - California Medical Laboratories IncTerminatedJan 7, 2013
Rigid Tip Suction Wand
California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Z-0650-2013 · View FDA record ↗ - International Biophysics CorpTerminatedNov 23, 2011
IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATI
Potential for the sterility to be compromised.
Z-0273-2012 · View FDA record ↗ - Terumo Cardiovascular Systems CorporationTerminatedOct 17, 2011
Sarns Rigid Intracardiac Sucker.
Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.
Z-0053-2012 · View FDA record ↗ - Terumo Cardiovascular Systems CorporationTerminatedOct 17, 2011
SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE
Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.
Z-0054-2012 · View FDA record ↗ - Terumo Cardiovascular Systems CorporationTerminatedAug 4, 2009
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.
Z-2046-2009 · View FDA record ↗ - California Medical Laboratories IncTerminatedJun 11, 2008
CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. REF SU-20601; CalMed Laboratories, Costa Mesa, CA 92626
Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
Z-1175-2008 · View FDA record ↗ - California Medical Laboratories IncTerminatedJun 11, 2008
CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626
Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
Z-1176-2008 · View FDA record ↗
Registered firms
27 firms currently registered for this product code
Sorin Group Italia S.r.l
MIRANDOLA Modena, IT
Temed
Sidlesham West Sussex, GB
Medtronic Perfusion Systems
Minneapolis, MN, US
Qsa Surgical (pvt) Ltd.
SIALKOT Punjab, PK
Sterigenics Us Llc
Los Angeles, CA, US
Smt Schilling Metalltechnik Gmbh
MUHLHEIM Baden-Wurttemberg, DE
Pemco, Inc.
Cleveland, OH, US
Medline Industries, Lp (northpoint Services)
Waukegan, IL, US
Medtronic Mexico S. De R.l. De Cv
Tijuana Baja California, MX
Isomedix Operations Inc
EL PASO, TX, US
Ultimate Medical Products Ltd.
SHARJAH Ash Shariqah, AE
Steris Corporation
Saint Louis, MO, US
Hnm Medical Dba Hnm Total Recon
Miami, FL, US
Terumo Bct Sterilization Services, Inc.
LAKEWOOD, CO, US
Armm, Inc.
HUNTINGTON BEACH, CA, US
Medtronic Grand Rapids
Grand Rapids, MI, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Sterigenics U.s., Llc
Corona, CA, US
Livanova Usa, Inc.
ARVADA, CO, US
Novosci Corp.
Conroe, TX, US
Steril Verona Srl
Nogara Verona, IT
Aspen Surgical Products, Inc.
Caledonia, MI, US
510(k) clearances
9 clearances for this product code
- Estech, Inc.Jan 26, 2006
K053021 · ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
- California Medical Laboratories, Inc.Sep 30, 1998
K982891 · CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
- International Biophysics Corp.Nov 14, 1997
K963756 · IBC CARDIAC SUCTION WARD
- Gish Biomedical, Inc.Jan 23, 1991
K905008 · FLEXIBLE INTRACARDIAC SUCTION DEVICE
- Shiley, Inc.Mar 28, 1990
K900339 · HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES
- Gish Biomedical, Inc.Jun 13, 1989
K891906 · ROBICSEK INTRACARDIAC SUCTION WAND
- Ohio Medical ProductsJul 28, 1980
K801641 · OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT
- Texas Medical Products, Inc.Jun 30, 1980
K801400 · DISPOSABLE SUCKER SYSTEM