DLP® 75318Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20643169084425), received between Jul 3, 2025 and Nov 24, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Misassembled During Installation” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K840001); 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT PRIOR TO USE, A PACKAGING IRREGULARITY OCCURRED INVOLVING THE DL STRAIGHT TIP ARTERIAL CANNULAE, WHERE CANNULA 75324 WAS FOUND IN THE 75318 CANNULA PACK. THE CANNULA (B)(4) PACK CONTAINED (B)(4) PIECES OF CANNULA 75324 INSTEAD OF ONLY CANNULA (B)(4) ITEMS AS EXPECTED. THE CANNULAE WILL BE USED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICES WERE NOT RE-PACKED AT THE FACILITY, AND THE PACKAGES WERE NOT RE-LABELLED AT THIS FACILITY MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT (B)(4) UNITS OF 75324 CANNULAE WERE INCLUDED IN THE BOX LABELLED AS 75318 CANNULA. INSTEAD OF CONTAINING ONLY 20 UNITS OF 75318 CANNULA, THE BOX HAD (B)(4) UNITS OF CANNULAE IN TOTAL. IT CONTAINED (B)(4) UNITS OF 75318 AND (B)(4) UNITS OF 75324.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629767 ↗
• MalfunctionNov 24, 2025Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT PRIOR TO USE, A PACKAGING IRREGULARITY OCCURRED INVOLVING THE DL STRAIGHT TIP ARTERIAL CANNULAE, WHERE CANNULA 75324 WAS FOUND IN THE 75318 CANNULA PACK. THE CANNULA 75318 PACK CONTAINED 3 PIECES OF CANNULA 75324 INSTEAD OF ONLY CANNULA 75318 ITEMS AS EXPECTED. THE CANNULAE WILL BE USED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICES WERE NOT RE-PACKED AT THE FACILITY, AND THE PACKAGES WERE NOT RE-LABELLED AT THIS FACILITY MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT 3 UNITS OF 75324 CANNULAE WERE INCLUDED IN THE BOX LABELED AS 75318 CANNULA. INSTEAD OF CONTAINING ONLY 20 UNITS OF 75318 CANNULA, THE BOX HAD 23 UNITS OF CANNULAE IN TOTAL. IT CONTAINED 20 UNITS OF 75318 AND 3 UNITS OF 75324.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629732 ↗
• MalfunctionNov 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE OF THE DLP STRAIGHT TIP ARTERIAL CANNULA, THE TIP OF THE CANNULA PRESENTED A DEFORMITY. THE DEVICE WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567500 ↗
• MalfunctionNov 3, 2025Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT PRIOR TO USE, A PACKAGING IRREGULARITY OCCURRED INVOLVING THE DL STRAIGHT TIP ARTERIAL CANNULAE, WHERE CANNULA 75324 WAS FOUND IN THE 75318 CANNULA PACK. THE CANNULA 75318 PACK CONTAINED 20 PACKS OF CANNULA 75318 AND 3 PACKS OF CANNULA 75324 INSTEAD OF ONLY CANNULA 75318 PACKS AS EXPECTED. THE CANNULAE WILL BE USED.THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448825 ↗
• MalfunctionJul 3, 2025Contamination; Contamination

  IT WAS REPORTED THAT WHEN OPENING THE DLP STRAIGHT TIP ARTERIAL CANNULA IN A STERILE MANNER IN A SURGICAL ENVIRONMENT, A DARK SPOT WAS FOUND ON THE EQUIPMENT. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT IMPACT HAS BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392637 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K840001. One submission often covers many models, so check the product and lot details in each record.

• Z-1925-2008 · May 9, 2008 · Terminated
  Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog Numbers: CB71424, CB77008, and CB77010.