PIPELINE 288210014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034220710), received between Aug 4, 2017 and Feb 27, 2023 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Inaccurate Information; Inaccurate Information

  DEVICE REPORT FROM TAIWAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS FOUND THAT LOCAL CHINESE LABEL OF PRODUCT (CODE: 288210014) WAS INCONSISTENT WITH THE LICENSE INFORMATION OF MANUFACTURE. THERE WAS NO REPORTED PATIENT INTERACTION. THIS REPORT IS FOR A PIPELINE ACCESS SYSTEM RIGID ARM ATTACHMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443739 ↗
• MalfunctionAug 4, 2017Material Deformation; Material Deformation

  NOTIFIED BY (B)(6). A COMPLAINT WAS CALLED INTO CUSTOMER SERVICE FOR THIS EVENT. IT INVOLVED PARTS FROM TWO (B)(6) KITS. SO WE PULLED THE 288210014 ¿ RIGID ARM ATTACHMENT ¿ FROM PIPEB # 17 AND WE PULLED THE 292900610 ¿ SPOT TABLE CLAMP - FROM SPLRAB # 60. THE 288210014 FEELS A LITTLE SHARP AROUND THE EDGE AND THE 292900610 ¿ IS MISSING THE WASHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768318 ↗