DLP® 94915Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20643169454808), received between Apr 11, 2023 and May 31, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K953945); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Certain lots of product have the potential for a sterile barrier breach.

   Z-2221-2026 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, A HOLE WAS OBSERVED IN THE SILICONE RCSP CANNULA. THE CANNULA WAS REPLACED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. ADDITIONAL INFORMATION: THE LOCATION OF THE HOLE WAS ASKED BUT IS UNKNOWN. THERE WAS NO DAMAGE TO THE PACKAGING. NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029271 ↗
• MalfunctionApr 11, 2023Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF, THE CUSTOMER REPORTED THAT THE RETROGRADE CANNULA LEAKED DURING USE. THE CUSTOMER DID NOT USE ANY SUTURE TO TIE THE CANNULA TO A DRAPE. WHEN CARDIOPLEGIA WAS BEING DELIVERED THE CANNULA SPRAYED CARDIOPLEGIA/BLOOD, SOME DID REACH THE SURGEON BUT IT DID NOT CAUSE ANY HARM. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.  THE CUSTOMER STATED THAT NO DAMAGE WAS NOTED TO THE CANNULA PRIOR TO USING IT AND THERE WAS NO TRAUMA DURING USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE PATIENT LOST LESS THAN 10ML OF BLOOD AS A RESULT OF THIS LEAK. NO TRANSFUSION WAS REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16714376 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953945. One submission often covers many models, so check the product and lot details in each record.

• Z-2219-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
• Z-2214-2026 · Apr 21, 2026 · Open, Classified
  Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
• Z-2218-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
• Z-2217-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
• Z-2220-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
• Z-2222-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
• Z-2216-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter