Medtronic Perfusion Systems Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
The following Model / Lot Number are affected: CB4W39R1 / 4876667, 0A84R2 / 4531036, 1708R18 / 4627100, 0V68R4 / 4212182, 1P07R6 / 4433014, 1P07R6 / 4678134, 2Y91R / 4628170, 2Y91R / 4800224, 2Y91R / 4902036, CB0Q49R14 / 4800849, 4D87R2 / 4184927.
Products Sold
The following Model / Lot Number are affected: CB4W39R1 / 4876667; 0A84R2 / 4531036; 1708R18 / 4627100; 0V68R4 / 4212182; 1P07R6 / 4433014; 1P07R6 / 4678134; 2Y91R / 4628170; 2Y91R / 4800224; 2Y91R / 4902036; CB0Q49R14 / 4800849; 4D87R2 / 4184927.
Medtronic Perfusion Systems is recalling Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product we due to An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not mee. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.
Recommended Action
Per FDA guidance
An Important Customer Notification, dated 09/06/06, was sent to affected customers. The letter identifies the affected model and lot numbers. Medtronic requests that affected product be returned. A suplemental pack can be built and shipped to the customer upon request. Medtronic will replace all returned product. A Recall Certificate is asked to be completed by customer and faxed to Medtronic.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IL, IN, LA, TN
Page updated: Jan 10, 2026