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Home Medtronic Issues Class I Recall for DLP Left Heart Vent Catheters Following FDA Warning and Three Serious Injuries

Medtronic Issues Class I Recall for DLP Left Heart Vent Catheters Following FDA Warning and Three Serious Injuries

Aug 24, 2025 16:00 CST Updated 16:00
Medtronic

Medical Device Manufacturer

FDA to the publicAlertShow MedtronicProduced inPartLeft Heart Drainage CatheterSafety issues.
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Products Involved
DLP Left Heart Drainage Catheter:Suitable for left heart drainage during extracorporeal circulation heart surgery, with a usage duration not exceeding 6 hours.
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Involved batches
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Reason for Warning

Medtronic's report shows that the affected products have difficulties in maintaining shape after bending. The design feature of this catheter requires its tube to possess the ability for plastic deformation and shape retention.

Potential Risks

  • Preoperative discovery of this issue may lead to surgical delay (requiring an alternative intubation).

  • If a problematic catheter is used during the procedure, it may cause tissue issues.Wear and Perforation (i.e., Incised Wounds)

  • Perforation of critical cardiac tissues, if followed by complications, undetected, or left untreated, can be life-threatening.

As of July 28, Medtronic had received3 Serious Injury Reports, no deaths.

Medtronic Initial Solutions

  • Check the inventory for labeled products

  • Immediately seal all unused related products.