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Suction tip

SORIN GROUP ITALIA SRL · Model SU-26702 · UDI-DI 08033178018746

DTS Prescription
9
510(k) clearances
243
Adverse events (3 deaths)
11
Recalls
24
Facilities

Recalls

DateFirmReason
2024-03-19Medtronic Perfusion SystemsPotential for unsealed sterile packing.
2015-08-07International Biophysics Corp.It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
2012-11-02California Medical Laboratories IncCalifornia 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 l
2012-11-02California Medical Laboratories IncCalifornia 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 l
2011-10-05International Biophysics CorpPotential for the sterility to be compromised.
2011-09-13Terumo Cardiovascular Systems CorporationTerumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.
2011-09-13Terumo Cardiovascular Systems CorporationTerumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.
2008-02-05Terumo Cardiovascular Systems CorporationA loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.
2008-01-24California Medical Laboratories IncFragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
2008-01-24California Medical Laboratories IncFragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.