Manufacturer
116 recalls in our database name Medtronic Perfusion Systems as the manufacturing or recalling firm.
Of the 116 recalls from Medtronic Perfusion Systems we have scored against our rubric, 4 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (9%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.
DLP Left Heart Vent Catheters, model 12115, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 25,261 units are affected.
Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.
Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.
Medtronic Perfusion Systems is recalling Select Series Angled Tip Arterial Cannulas (Model 72422) due to incorrect labeling. The recall involves 440 units distributed nationwide.
Medtronic is recalling 745 DLP Pediatric Arterial Cannulae (Models 77008 and 77014) due to incorrect labeling affecting seven manufactured lots distributed nationwide and worldwide.
Medtronic is recalling 420 units of DLP Aortic Root Cannulas due to a potential sterility breach caused by a misaligned seal.
Medtronic Perfusion Systems is recalling 290 units of DLP Single Stage Venous Cannulae due to a manufacturing error where straight-tip cannulae were placed into packaging labeled for right-angle metal-tip cannulae.
Medtronic is recalling 636 units of TourniKwik Tourniquet Sets due to incorrect components placed in four manufactured lots. Distribution includes the US states of Minnesota, Massachusetts, Utah, California, Florida, Japan, and Slovenia.
Medtronic is recalling 5,719 vessel cannulae units due to potential for unsealed sterile packing, affecting worldwide distribution.
Medtronic Intracoronary Shunts may have compromised sterile packaging, potentially allowing contamination. The FDA Class II recall affects 1,410 units distributed worldwide.
Medtronic recalls over 13,000 Left Heart Vent Catheter units due to potential for unsealed sterile packing. Affected devices distributed worldwide.
Medtronic recalled 250 units of DLP Coronary Ostial Cannulae (Model 30050) due to potential unsealed sterile packing. Lot 2023070529 was distributed worldwide.
Medtronic is recalling 7,935 units of I.M.A. Arteriotomy Cannula Model 31001 worldwide due to potential for unsealed sterile packing. Affected healthcare providers should verify lot numbers against inventory.
Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae due to potential for unsealed sterile packaging. The devices were distributed worldwide to healthcare facilities.
Medtronic is recalling seven models of cardioplegia adapters due to potential unsealed sterile packaging, which could compromise equipment sterility in cardiac surgery. No illnesses have been reported.
Medtronic Perfusion Systems is recalling multiple arterial cannula models worldwide due to potential for unsealed sterile packing. Compromised packaging may allow contamination of devices intended for clinical use.
Medtronic is recalling 500 units of Clearview Blower/Mister Model 22120 due to potential for unsealed sterile packing that could compromise device sterility.
Medtronic is recalling multiple models of suction tubes due to potential for unsealed sterile packing, which could compromise device sterility. Affected customers should refer to the official FDA recall notice for lot details.
Medtronic is recalling aortic root cannulae and cardioplegia needles used in cardiac surgery due to potential unsealed sterile packaging. Approximately 2,622 units were distributed worldwide.
Medtronic is recalling 1760 tourniquet kits due to potential for unsealed sterile packing. These surgical devices may have compromised sterilization barriers.
Medtronic Perfusion Systems recalls 1,624 Disposable Pressure Display Sets (Models 61000 and 62000) distributed worldwide due to potential for unsealed sterile packing. No illnesses or injuries have been reported.
Medtronic is recalling 4,343 units of DLP Vessel Cannula (Model REF 30000) due to incorrect labeling on three manufactured lots distributed globally.
Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator due to reports that the Temperature Monitoring Adapter can come loose during or after use in cardiopulmonary bypass procedures.
Medtronic is recalling cardiopulmonary bypass equipment because the Temperature Monitoring Adapter can come loose during setup or disassembly, potentially compromising temperature monitoring during heart surgery.