Surfacer®Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450762158), received between Nov 25, 2025 and Aug 20, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50356342 ↗
• InjuryNov 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IN A LITERATURE ARTICLE (BOHLE, 2023), CUSTOMER REPORTS " DURING SURFACER INSIDE-OUT CENTRAL VENOUS RECANALIZATION, PATIENT SUSTAINED RIGHT INTERNAL MAMMARY ARTERY LACERATION WITH MASSIVE HEMOTHORAX AND CARDIOVASCULAR COLLAPSE; MANAGED WITH TRANSFUSION, CHEST TUBE, AND ARTERIAL COIL EMBOLIZATION. DEVICE USE INTRA-PROCEDURE IMPLICATED; ADVANCED IMAGING SUGGESTED INJURY RISK ALONG PROJECTED DEVICE PATH."

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Hemothorax

  MAUDE report 23658628 ↗
• InjuryNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IN A LITERATURE ARTICLE (PUPPALA ET AL., 2025), CUSTOMER REPORTS " AN ADVERSE EVENT ASSOCIATED WITH THE SURFACER SYSTEM WAS IDENTIFIED IN A 2025 U.S. CASE REPORT. A PATIENT SUFFERED A CARDIAC ARREST DURING OR FOLLOWING SURFACER PROCEDURE. DETAILS OF RESUSCITATION AND PATIENT OUTCOME WERE NOT SPECIFIED IN THE ABSTRACT BUT WERE TEMPORALLY LINKED TO THE DEVICE USE."

  Patient problems: Cardiac Arrest

  MAUDE report 23645279 ↗
• InjuryNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IN A LITERATURE ARTICLE (BOHLE ET AL., 2023), CUSTOMER REPORTS "A 71-YEAR-OLD FEMALE UNDERGOING SURFACER INSIDE-OUT CENTRAL VENOUS CATHETER PLACEMENT FOR THORACIC CENTRAL VENOUS OCCLUSION EXPERIENCED A NEAR-FATAL ARTERIAL INJURY. DURING ADVANCEMENT OF THE DEVICE, THE RIGHT INTERNAL MAMMARY ARTERY WAS INADVERTENTLY LACERATED, RESULTING IN MASSIVE BLEEDING AND CARDIOVASCULAR COLLAPSE. THE PATIENT REQUIRED TRANSFUSION, CHEST TUBE PLACEMENT, AND COIL EMBOLIZATION OF THE INJURED ARTERY. IMAGING REVIEW POST-PROCEDURE REVEALED THE TRAJECTORY OF THE DEVICE INTERSECTED THE ARTERY, INDICATING POTENTIAL FOR INJURY DUE TO ANATOMICAL VARIATION. THE EVENT RESULTED IN HEMOTHORAX AND PROLONGED HOSPITALIZATION, BUT THE PATIENT ULTIMATELY RECOVERED."

  Patient problems: Hemothorax

  MAUDE report 23645271 ↗