VC2™ 93448CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994887256), received between Dec 20, 2021 and Dec 20, 2021 — classified as 1 malfunction.

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

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

3 other recalls cover devices cleared under the same FDA submission (K845045); 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. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1805-2024 · Root cause: 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.

• MalfunctionDec 20, 2021Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS VC2 ATRIAL CAVAL VENOUS CANNULA, DURING DECANNULATION AFTER THE END OF EXTRACORPOREAL CIRCULATION THE END OF THE CANNULA INSERTED IN THE EAR OF THE RIGHT ATRIUM OF THE PATIENT'S HEART DISINTEGRATED INTO 2 PARTS. THE SURGEON MANAGED TO REMOVE THE PART THAT REMAINED IN THE PATIENT IMMEDIATELY, SO THERE WAS NO DAMAGE TO THE PATIENT. PATIENT STATUS AT THE TIME OF THIS REPORT IS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION: THE CUSTOMER DID NOT REQUIRE ADDITIONAL DEVICES TO REMOVE THE PARTS THAT HAD FALLEN INTO THE PATIENT. THE CANNULA DID NOT COME APART WHERE IT WAS TIED. THE CUSTOMER STATED THAT AN INSTRUMENT OR DEVICE WAS NOT HOLDING THE CANNULA, THE CANNULA WAS FIXED WITH A STANDARD TURNSTILE SUTURE. A 2-0, CARDIOXYL SUTURE WAS USED TO HOLD THE CANNULA. THE CUSTOMER STATED THAT THE CANNULA WAS BROKEN OUTSIDE THE FIXATION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042080 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K845045. One submission often covers many models, so check the product and lot details in each record.

• Z-0812-2012 · Dec 14, 2011 · Terminated
  Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic. Model # 's CB66112, CB66114, CB66116,
• Z-0808-2012 · Dec 14, 2011 · Terminated
  Medtronic DLP, DLP Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model #'s 66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134,
• Z-1489-04 · Sep 15, 2004 · Terminated
  Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.