Sucker, Cardiotomy Return, Cardiopulmonary Bypass
FDA adverse event reports and recall history for sucker, cardiotomy return, cardiopulmonary bypass (product code DTS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 242
- Deaths
- 3
- Injuries
- 51
- Malfunctions
- 176
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-05-10Open, ClassifiedProcess control
Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10053, d) DLP Suction Tube 10 Fr. Shaft with 20 Fr. Pool Tip, Model Number: 10060, e) DLP Suction Tube 16 Fr. Shaft with 20 Fr. Fluted Tip, Model Number: 10061
Potential for unsealed sterile packing.
- 2015-08-19TerminatedPackaging process control
IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
- 2013-01-07TerminatedNonconforming Material/Component
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
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.
- 2013-01-07TerminatedNonconforming Material/Component
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
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.
- 2011-11-23TerminatedPackaging
IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015 For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems.
Potential for the sterility to be compromised.
- 2011-10-17TerminatedNonconforming Material/Component
Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector
Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.
- 2011-10-17TerminatedNonconforming Material/Component
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.
- 2009-08-04TerminatedProcess control
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.
- 2008-06-11TerminatedProcess control
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.
- 2008-06-11TerminatedProcess control
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.
Monitor sucker, cardiotomy return, cardiopulmonary bypass automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.