NA BTC93Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00673978522548), received between Dec 6, 2018 and Dec 6, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

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

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. Nov 27, 2018Open, Classified

   Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.

   Z-0786-2019 · Root cause: Process control · 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.

• MalfunctionDec 6, 2018Defective Component; Defective Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE BTC93 SUCTION LINE LEAKED. THE PRODUCT WAS REPLACED. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8137389 ↗
• MalfunctionDec 6, 2018Defective Component; Defective Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE SUCTION AND ANTICOAGULANT LINE LEAKED WHEN THE CUSTOMER HOOKED IT UP TO SALINE. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVED SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8137359 ↗