DLP® 94215TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169454556), received between Jul 9, 2024 and Jul 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

8 other recalls cover devices cleared under the same FDA submission (K860149); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

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

   Z-2216-2026 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE AS THE CUSTOMER WAS CONNECTING THE SLIP TIP SYRINGE TO THE DEVICE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699989 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K860149. One submission often covers many models, so check the product and lot details in each record.

• Z-2220-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
• Z-2215-2026 · Apr 21, 2026 · Open, Classified
  Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
• Z-2221-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; 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-2217-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; 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-2219-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; 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