Manufacturer

Medtronic Perfusion Systems

78 recalls in our database name Medtronic Perfusion Systems as the manufacturing or recalling firm.

About this listing

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.

51–75 of 78

HighFDA (Devices)·Z-0003-2022·2021-10-13
Medtronic Insertion Kits Recalled for Incorrect Guidewire Label Mix-Up
Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.
Product
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2504-2021·2021-09-29
DLP Left Heart Vent Catheters recalled due to potential wire protrusion
Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.
Product
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2505-2021·2021-09-29
DLP Left Heart Vent Catheters Recalled for Potential Wire Protrusion
Medtronic recalls DLP Left Heart Vent Catheters due to risk of wire protrusion through the catheter tip. The defect could cause internal injury during cardiac procedures.
Product
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1887-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Defective Welding
Medtronic has recalled 16 tubing packs from its CB10R79R6 Custom Perfusion System due to insufficient or incomplete welds in specific lots. The defect may compromise device integrity during use.
Product
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1878-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic is recalling specific lots of CB1H18R20 Custom Perfusion System tubing packs because they may have been manufactured with insufficient or incomplete welds. No injuries have been reported.
Product
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1881-2021·2021-06-23
Medtronic Cardiac Perfusion Tubing Packs Recalled Due to Defective Welds
Medtronic is recalling specific lots of CB4W67R20 Custom Perfusion System tubing packs due to incomplete welds that could affect system performance. The recall affects 61 packs distributed across nine states.
Product
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1891-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic is recalling specific lots of CB10Y89R10 custom perfusion system tubing packs due to insufficient or incomplete welds. The affected lots were distributed in nine U.S. states.
Product
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1893-2021·2021-06-23
Medtronic Custom Perfusion System Tubing Packs Recalled Due to Welding Defects
Medtronic is recalling 26 tubing packs from its Custom Perfusion System (Lot 221148857) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.
Product
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects
Medtronic is recalling specific lots of HY10Z48R2 Adult ECC Custom Perfusion System tubing packs due to potential weld defects. Affected units may have insufficient or incomplete welds that could compromise device function.
Product
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1877-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic is recalling 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.
Product
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1880-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Defective Welds
Medtronic is recalling specific lots of Custom Pack HY8R62R13 E Pack perfusion system tubing due to manufacturing defects. Affected lots may have incomplete welds that could compromise device function during use.
Product
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1892-2021·2021-06-23
Medtronic Cardiac Perfusion Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling specific lots of BB8M63R5 adult cardiac perfusion tubing packs due to incomplete welds in the manufacturing process. These defects could compromise tubing integrity during cardiac surgery.
Product
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1890-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling HY10L28R3 perfusion system tubing packs (lot 221679870) manufactured with insufficient or incomplete welds. The recall affects units distributed in nine U.S. states.
Product
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1884-2021·2021-06-23
Medtronic Custom Perfusion System Recalled for Incomplete Welds
Specific lots of Medtronic's CB10W65R1 perfusion system tubing packs may have incomplete or insufficient welds that could compromise system integrity during cardiac surgery.
Product
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1882-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic is recalling perfusion system tubing packs due to manufacturing defects involving incomplete or insufficient welds. No injuries have been reported, but the defect may affect product performance and safety.
Product
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1885-2021·2021-06-23
Medtronic perfusion tubing packs recalled for manufacturing weld defects
Medtronic recalls 11 packs of HY10Y54R4 Custom Perfusion System tubing manufactured with insufficient or incomplete welds. No injuries have been reported.
Product
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1889-2021·2021-06-23
Medtronic perfusion system tubing packs recalled due to weld defects
Medtronic is recalling specific lots of CB7J98R7 Custom Pack perfusion system tubing because some units may have insufficient or incomplete welds. The defect could affect device performance during cardiac surgery.
Product
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1879-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Insufficient Welds
Medtronic Perfusion System tubing packs are recalled due to manufacturing defects involving insufficient or incomplete welds in the CB10W63R1 lot. Affected devices may malfunction during use.
Product
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2021·2021-06-23
Medtronic Custom Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic recalls Custom Perfusion System tubing packs due to incomplete welds in the manufacturing process that may affect device integrity.
Product
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1876-2021·2021-06-23
Medtronic Custom Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic recalls custom perfusion system tubing packs due to potential manufacturing defects in welds. Specific lots may have insufficient or incomplete welds that could affect system integrity.
Product
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1888-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Defective Welds
Medtronic is recalling CB10R55R5 perfusion system tubing packs due to insufficient or incomplete welds that could compromise device function. The recall affects five tubing packs distributed across nine U.S. states.
Product
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects
Medtronic recalls specific lots of HY8M63R4 Adult ECC Custom Perfusion System tubing packs due to potentially insufficient or incomplete welds, which could affect performance during surgical procedures.
Product
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1883-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling 14 tubing packs of its HY10J00R12 perfusion system due to insufficient or incomplete welds. The affected lot is 221227814 with a use-by date of August 28, 2022.
Product
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling specific lots of BB10R94R6 Custom Perfusion System tubing packs due to incomplete or insufficient welds. The defect may affect device performance during use.
Product
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.
Product
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide