Home › Device types › DTS
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
FDA product code DTS · Class 2 · Cardiovascular
94
Registered devices
243
Adverse events
11
Recalls
9
510(k) clearances
Devices with this code
Suction tip — LIVANOVA USA, INC.PEMCO INC — PEMCO INCSuction tip — LIVANOVA USA, INC.DLP® — MEDTRONIC, INC.PEMCO INC — PEMCO INCPEMCO INC — PEMCO INCPEDIATRIC GROOVED TIP SUCKER — NOVOSCI CORP.ADULT SUMP SUCKER HEX HANDLE — NOVOSCI CORP.PEMCO INC — PEMCO INCIntracardiac Sucker — SORIN GROUP ITALIA SRLSuction tip — SORIN GROUP ITALIA SRLINFANT GROOVED TIP SUCKER — NOVOSCI CORP.Suction tip — SORIN GROUP ITALIA SRLV. Mueller — STERIS CORPORATIONPEMCO INC — PEMCO INCIBC Suction Wand (Non Sterile) — Movair, Inc.Suction tip — LIVANOVA USA, INC.DLP® — MEDTRONIC, INC.Suction tip — LIVANOVA USA, INC.ADULT GROOVED TIP SUCKER — NOVOSCI CORP.IBC Mini Sucker (Sterile) — Movair, Inc.PEMCO INC — PEMCO INCSuction tip — SORIN GROUP ITALIA SRLPEMCO INC — PEMCO INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-19 | Medtronic Perfusion Systems | Potential for unsealed sterile packing. |
| 2015-08-07 | International Biophysics Corp. | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. |
| 2012-11-02 | California Medical Laboratories Inc | California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the |
| 2012-11-02 | California Medical Laboratories Inc | California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the |
| 2011-10-05 | International Biophysics Corp | Potential for the sterility to be compromised. |
| 2011-09-13 | Terumo Cardiovascular Systems Corporation | Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intr |
| 2011-09-13 | Terumo Cardiovascular Systems Corporation | Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intr |
| 2008-02-05 | Terumo Cardiovascular Systems Corporation | A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient. |
| 2008-01-24 | California Medical Laboratories Inc | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. |
| 2008-01-24 | California Medical Laboratories Inc | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.